Endoscopic sleeve gastroplasty reintervention score using supervised machine learning.

BACKGROUND AND AIMS: Reintervention after endoscopic sleeve gastroplasty (ESG) can be indicated because of postprocedural adverse events from various preinterventional or postprocedural comorbidities. We developed and internally validated an ESG reintervention score (ESG-RS) that determines the individualized risk of reintervention within the first 30 days after ESG. METHODS: We used data from a sample of 3583 patients who underwent ESG in the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program database (2016-2021). The least absolute shrinkage and selection operator (LASSO)-penalized regression was used to select the most promising predictors of reintervention after ESG within 30 days. The predictive variables extracted by LASSO regression were entered into multivariate analysis to generate an ESG-RS by using the coefficients of the statistically significant variables. The model performance was assessed using receiver-operator curves by 10-fold cross-validation. RESULTS: Eleven variables were selected by LASSO regression and used in the final multivariate analysis. The ESG-RS was inferred using 5 factors (history of previous foregut surgery, preoperative anticoagulation use, female gender, American Society of Anesthesiologists class ≥II, and hypertension) weighted by their regression coefficients in the multivariable logistic regression model. The area under the curve of the ESG-RS was .74 (95% confidence interval, .70-.78). For the ESG-RS, the optimal cutpoint was 67.9 (high risk vs low risk), with a sensitivity of .76 and specificity of .71. CONCLUSIONS: The ESG-RS aids clinicians in preoperative risk stratification of patients undergoing ESG while clarifying factors contributing to a higher risk of reintervention.

Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity.

BACKGROUND & AIMS: The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. METHODS: Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. RESULTS: 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m2) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P < .01). POSE 2.0 reduced maximum tolerated meal volume (P = .03) and was associated with increased fullness (P < .01) and improved eating behavior (P < .01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P < .01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. CONCLUSION: POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. CLINICALTRIALS: gov Identifier: NCT03721731.

Nutritional Management and Role of Multidisciplinary Follow-Up after Endoscopic Bariatric Treatment for Obesity.

The prevalence of obesity has risen exponentially, and patients living with obesity suffer from its debilitating consequences. The treatment options for obesity have expanded significantly and include lifestyle changes, pharmacotherapy, endoscopic bariatric therapies (EBTs), and bariatric surgery. Endoscopic bariatric therapies comprise volume-reducing procedures such as endoscopic gastroplasty and gastric space-occupying devices such as intragastric balloons. Because of its minimally invasive nature and ease of delivery, EBTs are increasingly being adopted as a treatment option for obesity in several centers. These procedures mainly achieve weight loss by inducing early satiety and reducing meal volume. While the technical aspects of EBTs have been well explained, the nutritional management surrounding EBTs and the effectiveness of multidisciplinary team for maximizing weight loss is less described. There is considerable variation in post-EBT care between studies and centers. In this paper, we review the existing literature and share our experience on nutrition and the role of multidisciplinary management of obesity following EBT.

Effects on physiologic measures of appetite from intragastric balloon and endoscopic sleeve gastroplasty: results of a prospective study.

BACKGROUND: Endoscopic bariatric therapies can help address widening management gaps in obesity. Their ability to facilitate weight loss is largely tied to influences on appetite through perturbations of gastric emptying and accommodation. As these tools gain traction in obesity therapy, their physiologic underpinnings require exploration, which may enhance efficacy, tolerance, and patient-tailored care. METHODS: We prospectively assessed consecutive subjects with fluid-filled intragastric balloons (IGBs) ( n  = 18) placed between October 2016 and June 2017 or underwent endoscopic sleeve gastroplasty (ESG) ( n  = 23) from March 2018 to June 2018. Patients underwent physiologic appraisal at 3 months with 13 C-spirulina-based gastric emptying breath test to determine time to half emptying (T50), as well as maximum tolerated volume (MTV) of a standard nutrient drink test. Changes in T50 and MTV at 3 months were compared with percent total body weight loss (%TBWL) at 3 and 6 months using best-fit linear regression. RESULTS: The change in T50 at 3 months correlated with %TBWL at 3 months for IGB ( P  = 0.01) and ESG ( P  = 0.01) but with greater impact on %TBWL in IGB compared to ESG ( R2  = 0.42 vs . 0.26). Change in T50 at 3 months was predictive of weight loss at 6 months for IGB ( P  = 0.01) but not ESG ( P  = 0.11). ESG was associated with greater decrease in MTV compared to IGB (340.25 ±â€Š297.97 mL vs. 183.00 ±â€Š217.13 mL, P  = 0.08), indicting an enhanced effect on satiation through decreased gastric accommodation. Changes in MTV at 3 months did not correlate with %TBWL for either IGB ( P  = 0.26) or ESG ( P  = 0.49) but trended toward significance for predicting %TBWL at 6 months for ESG ( P  = 0.06) but not IGB ( P  = 0.19). CONCLUSION: IGB and ESG both induce weight loss but likely through distinct gastric motor function phenotypes, and gastric emptying may predict future weight loss in patients with IGB.

Review about Psychological Barriers to Lifestyle Modification, Changes in Diet Habits, and Health-Related Quality of Life in Bariatric Endoscopy.

Obesity is an expanding disease responsible for significant deterioration in the Health-Related Quality of Life (HRQL) of those who suffer from it. Bariatric Endoscopy (BE) therapies have proven to be an effective treatment for this pathology. A multidisciplinary approach is essential for the successful therapeutic management of BE. This article addresses the multidisciplinary treatment of BE by considering the possible variables that can influence treatment. In particular, the variables that can facilitate or hinder changes in patients' habits are discussed. These include the neuropsychological, emotional, and social implications that may influence the formation of healthy habits necessary for improvement in a patient's quality of life; the individual and environmental psychological factors that influence the monitoring of nutritional and physical activity indications; and different psychological disorders such as depression, anxiety, or disorders related to eating. The main objective of BE treatment, except in certain special biological situations, must be to establish a long-term sustainable change in habits such that patients, once they reach a healthy weight, do not revert to the lifestyle that caused their obesity, as well as identifying and addressing major problems that may exist prior to, or arise during, treatment.

Endoscopic sleeve gastroplasty (ESG) for morbid obesity: how effective is it?

INTRODUCTION: ESG is an effective treatment for classes I and II obesity. However, the benefit of ESG in patients with morbid obesity (BMI ≥ 40 kg/m2) who decline surgery is not known. The study aims to compare the effectiveness and safety of ESG in all three obesity classes at 1 year. METHODS: We reviewed 484 patient records and identified 435 patients (class I: 105, class II: 169, class III: 161) who underwent ESG at our unit between May 2013 and March 2020. We compared their total body weight loss (%TBWL) and safety over 1 year. We used a linear mixed model (LMM) to analyse repeated measures of weight loss outcomes at 3, 6, 9, and 12 months for comparison between the three BMI groups. RESULTS: Among the 435 patients, 396 patients (class I: 99, class II: 151, class III: 146) completed 6 months, and 211 patients reached 1 year (class I: 50, class II: 77, class III: 84). There was no difference in age between the groups. In LMM analysis, adjusting for age and sex, we found ESG had a significantly higher TBWL, %TBWL, and BMI decline in class III compared to classes I and -II obesity at all time points (p < 0.001). The adjusted mean %TBWL at 1 year with classes I, -II, and -III obesity was 16.5%, 18.2%, and 20.5%, respectively. The overall complication rate and the hospital stay was identical in the three groups. CONCLUSION: ESG induced significant weight loss in all classes of obesity. In class III obesity, the weight loss achieved was significantly higher at 1 year. In patients declining or unsuitable for surgery, ESG could be considered as an alternative treatment option.

Safety and early efficacy of endoscopic sleeve gastroplasty (ESG) for obesity in a multi-ethnic Asian population in Singapore.

BACKGROUND AND AIM: Endoscopic sleeve gastroplasty (ESG) is an alternative nonsurgical treatment option for obesity. However, most studies on the utility and efficacy of ESG are derived from the Western population. It is unknown if ESG elicits similar results in Asians with different fat distribution, sociocultural customs, and dietary practices. Our study aims to assess the safety and efficacy of ESG among a multi-ethnic Asian population. METHODS: We reviewed 35 patient records who underwent primary ESG for obesity at our unit. We followed a U-shaped suture pattern. Our primary outcome was to assess technical feasibility and safety. The secondary outcome was to determine the percentage total body weight loss (TBWL) at the last follow-up. RESULTS: The mean ± SD age and body mass index were 43.6 ± 11.3 years and 34 ± 4.9 kg/m2, respectively. The majority were female (57%) and of Chinese ethnicity (51%). The procedure was technically successful in all patients. We used an average of five sutures (range, 4-7), and the mean ± SD procedure time was 65 ± 10 min. No major complications occurred, and the average length of stay was 1 day. Twenty-one patients completed 3 months of follow-up, and 10 patients 6 months. The mean ± SD TBWL at 3 and 6 months were 14.5 ± 4.8% and 16.2 ± 4.9%, respectively. We observed improvement in diabetes mellitus (87%), fatty liver (86%), and hypertension (58%) during the follow-up. CONCLUSION: ESG is a safe and effective option for promoting weight loss in a multi-ethnic Asian population. ESG-induced weight loss may improve obesity-related comorbidities.

Endoscopic gastroplasty: an effective solution in a high-risk patient with morbid obesity.

A 61-year-old man was referred to the bariatric endoscopy unit for the management of morbid obesity (BMI 47 kg/m2). He had multiple obesity-related medical comorbidities. His weight gain started 8 years after suffering smoke inhalation syndrome following an industrial accident. He sustained permanent lung parenchymal injury resulting in impaired pulmonary function. His mobility was restricted to a wheelchair and was dependent on long term oxygen therapy. He tried diet and lifestyle intervention but could not achieve significant weight loss. He was referred for bariatric surgery but was declined because of substantial comorbidities, poor pulmonary function, anesthetic risk (ASA Class 4), and risk of complications. After depleting all of his options, he sought us for endoscopic therapy. Following a successful collaboration with the anesthetist, endocrinologist, and nutritionist, we performed an endoscopic gastroplasty using the modified primary obesity surgery endoluminal procedure (POSE-2) and reduced the gastric volume. He recovered immediately without complications and achieved significant weight loss at 10 months (41 kg). He is now able to walk, the oxygen requirements have decreased, and the comorbidities have significantly improved.

Re-suturing after primary endoscopic sleeve gastroplasty (ESG) for obesity.

INTRODUCTION: Although primary endoscopic sleeve gastroplasty (P-ESG) is effective, some patients may require revision procedures to augment weight loss. We hypothesized that a non-surgical approach using redo ESG (R-ESG) might be a viable option in such patients. We aimed to assess the safety and efficacy of R-ESG following P-ESG to treat obesity. METHODS: We reviewed the outcome of patients who underwent R-ESG at our unit. We classified them as weight loss failure (WF)-< 10% total body weight (TBWL) at 6-months; weight regain (WR)-lost ≥ 10% TBWL and regained 50% of the maximum weight loss at or after 1-year; weight plateau (WP)-lost ≥ 10% TBWL but could not lose further over 3-months. We analyzed the feasibility, safety, and evaluated the efficacy of R-ESG in each group. RESULTS: Of the 482 patients who underwent P-ESG, 35 (7%) required R- ESG (WF-12, WR-12, WP-11). The mean age, weight, BMI (38.2 kg/m2), and the number of sutures used during P-ESG were similar between the groups. The nadir %TBWL was lowest in WF group compared to WR and WP (6.5% vs. 20% vs. 22.4%, p = 0.001). The mean BMI at R-ESG was 33.6 kg/m2. The time to R-ESG was longer in the WR group compared to WF and WP (22.3 vs. 13.4 vs. 13.7 months, p = 0.03). We placed a median of 3 (range 2-6) sutures. R-ESG was technically successful, and no serious complications occurred. All except two patients were discharged on the same day. The overall %TBWL achieved by R-ESG was significantly higher in WP (26%) as compared to WF (11.2%) and WR (12%), respectively (p = 0.001). CONCLUSION: The need for R-ESG after P-ESG is low. R-ESG is safe and induced weight loss in all patients. The maximum benefit was observed in WP.

Endoscopic sleeve gastroplasty, laparoscopic sleeve gastrectomy, and laparoscopic greater curve plication: do they differ at 2 years?

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an effective treatment option for obesity. However, data comparing its efficacy to bariatric surgery are scarce. We aimed to compare the effectiveness and safety of ESG with laparoscopic sleeve gastrectomy (LSG) and laparoscopic greater curve plication (LGCP) at 2 years. METHODS : We reviewed 353 patient records and identified 296 patients who underwent ESG (n = 199), LSG (n = 61), and LGCP (n = 36) at four centers in Spain between 2014 and 2016. We compared their total body weight loss (%TBWL) and safety over 2 years. A linear mixed model (LMM) was used to analyze repeated measures of weight loss outcomes at 6, 12, 18, and 24 months to compare the three procedures. RESULTS : Among the 296 patients, 210 (ESG 135, LSG 43, LGCP 32) completed 1 year of follow-up and 102 (ESG 46, LSG 34, LGCP 22) reached 2 years. Their mean (standard deviation [SD]) body mass index (BMI) was 39.6 (4.8) kg/m2. There were no differences in age, sex, or BMI between the groups. In LMM analysis, adjusting for age, sex, and initial BMI, we found ESG had a significantly lower TBWL, %TBWL, and BMI decline compared with LSG and LGCP at all time points (P = 0.001). The adjusted mean %TBWL at 2 years for ESG, LSG, and LGCP were 18.5 %, 28.3 %, and 26.9 %, respectively. However, ESG, when compared with LSG and LGCP, had a shorter inpatient stay (1 vs. 3 vs. 3 days; P < 0.001) and lower complication rate (0.5 % vs. 4.9 % vs. 8.3 %; P = 0.006). CONCLUSION : All three procedures induced significant weight loss in obese patients. Although the weight loss was lower with ESG compared with other techniques, it displayed a better safety profile and shorter hospital stay.

Primary obesity surgery endoluminal (POSE-2) procedure for treatment of obesity in clinical practice.

BACKGROUND: The POSE-2 procedure shortens and narrows the stomach using multiple full-thickness plications in the gastric body. We studied the efficacy and safety of POSE-2 for obesity at 1 year in a real-world setting. METHODS: We reviewed the records of 75 patients who underwent POSE-2 at our unit. The primary outcome was percentage total body weight loss (%TBWL) at 1 year. Secondary outcomes were safety and durability. We used linear mixed model analysis. RESULTS: 46 patients completed 1 year. Mean age and body mass index (BMI) were 49.3 years (standard deviation [SD] 10.2) and 38.2 kg/m2 (SD 6.6), respectively. Technical success rate was 98.7 % (n = 74). Mean TBWL, %TBWL, and BMI decline at 1 year were 20 kg (SD 12.7), 17.8 % (SD 9.5), 7 kg/m2 (SD 4.3). Adverse events occurred in four patients. The median length of stay was 1 day. Endoscopy at 1 year in 15 patients showed intact sutures and a reduction in gastric length compared with baseline (26.9 cm [SD 5.3] vs. 35.7 cm [SD 3.5]; P < 0.001). CONCLUSION: POSE-2 induced significant weight loss at 1 year. It appears to be safe, durable, and required only a short hospital stay.

IFSO Endoscopy Committee Position Statement on the Practice of Bariatric Endoscopy During the COVID-19 Pandemic.

COVID-19 (Coronavirus disease 2019) caused by SARS-CoV-2 has become a global pandemic. Obesity is a risk factor for severe disease, and the practice of endoscopy poses special challenges and risks of SARS-CoV-2 transmission to patients and providers given the evolving role of the gastrointestinal tract in viral transmission and aerosol generation during endoscopic procedures. It is therefore necessary to distinguish between urgent interventions that cannot be postponed despite the risks during the pandemic and, in contrast, purely elective interventions that could be deferred in order to minimize transmission risks during a time of infection surge and limited access. Semi-urgent bariatric procedures have an intermediate position. Since the chronological course of the pandemic is still unpredictable, these interventions were defined according to whether or not they should be performed within a nominal 8-week period. In this position statement, the IFSO Endoscopy Committee offers guidance on navigating bariatric endoscopic procedures in patients with obesity during the COVID-19 pandemic, in the hope of mitigating the risk of SARS-CoV-2 transmission to vulnerable patients and healthcare workers. These recommendations may evolve as the pandemic progresses.

The effect of weight loss and exercise on Health-Related Quality of Life (HRQOL) following Endoscopic Bariatric Therapies (EBT) for obesity.

INTRODUCTION: Endoscopic bariatric therapies (EBT) have demonstrated to induce weight loss and improve comorbidities in obese patients. However, little is known about its impact on health-related quality of life (HRQOL) outcomes and physical activity status. This study aimed to evaluate the change in HRQOL and physical activity following EBT induced weight loss in obese patients. METHODS: We approached 181 patients who underwent EBT in a standardized multidisciplinary follow-up program to participate in the study. We provided them two questionnaires-a) Short Form-36 health survey with the physical (PSC) and mental (MSC) summary component scores to capture generic HRQOL, and b) international physical activity questionnaire (IPAQ) for physical activity (PA). We administered the survey at baseline and at 9 months post-procedure. We expressed the procedure outcome as percentage total body weight loss (%TBWL). We expressed continuous variables as mean (SD) or median and categorical variables as percentages. We used non-parametric tests for comparison and performed multivariable linear regression analysis to identify factors associated with improvement in HRQOL. RESULTS: The mean age was 42.2 (11.3) years, and the mean BMI was 38 (5.9)kg/m2. A majority of them were female (n-132, 73%). The EBT included intragastric balloons (n-136, 75%) and endoscopic sleeve gastroplasty (n-24, 25%). The mean %TBWL achieved after the intervention was 16.9 (9.7)%. We noticed a significant improvement in the median PSC (77.8 vs. 90.4, p < 0.001) and MSC (67 vs. 80.2, p < 0.001) scores after EBT. Similarly, we observed a significant positive change in physical activity compared to baseline (1606.2 vs. 2749 MET-minutes/week, p = < 0.001). Linear regression analysis showed an increase in %TBWL was associated with significant improvement in PSC (ß = 0.193, p = 0.003) and MSC (ß = 0.166, p = 0.02) scores of HRQOL, and likewise, increase in PA was independently associated with improvement in MSC (ß = 0.192, p = 0.01). We did not find any difference in outcome based on gender or the type of intervention. CONCLUSION: EBT improves HRQOL in obese patients regardless of the type of intervention. The weight loss induced by EBT and the improvement in PA positively influence the health outcomes and quality of life.

Personalization of Endoscopic Bariatric and Metabolic Therapies Based on Physiology: a Prospective Feasibility Study with a Single Fluid-Filled Intragastric Balloon.

BACKGROUND: The intragastric balloon (IGB) is commonly used for weight loss. Identifying patients who are most likely to tolerate and benefit from IGB therapy will optimize outcomes. Our aims were to prospectively utilize a gastric emptying study to predict intolerance and treatment response with a single fluid-filled IGB and to develop a physiologic prediction model with a treatment algorithm. MATERIALS AND METHODS: A total of 32 patients had a gastric emptying study before and 2-3 months after placement of an IGB. Multiple logistic regression analyses were performed to calculate likelihood ratios and to develop a physiologic prediction model. RESULTS: Patients in the higher gastric retention quartile at baseline had a 6.2-time higher likelihood ratio for early balloon removal secondary to intolerance (p = 0.013). Utilizing baseline gastric emptying to predict intolerance to the IGB may have prevented 75% of early removal cases. Decreased gastric emptying at 3 months after balloon placement was significantly correlated with percent total body weight loss (%TWBL) at 6 and 12 months (p = 0.01 and p = 0.014, respectively). At 6 months after IGB, patients with no change in their gastric emptying at 3 months lost significantly less weight compared with those with increased gastric retention (median %TBWL = 9.0% [4.5-14.7] versus 17.3% [12.2-24.4], p = 0.016). CONCLUSION: Utilizing gastric emptying as a physiologic predictor of intolerance and response to the single fluid-filled IGB can improve outcomes. This pilot feasibility trial ushers in the era of personalized endoscopic bariatric therapies to maximize patients' tolerance, cost-effectiveness, and meaningful weight loss.

Gut and Metabolic Hormones Changes After Endoscopic Sleeve Gastroplasty (ESG) Vs. Laparoscopic Sleeve Gastrectomy (LSG).

INTRODUCTION: ESG reduces gastric lumen similar to LSG and induces significant weight loss. However, the metabolic and physiological alteration after ESG is not fully understood. We aim to study the gastrointestinal hormone changes after ESG and compared it with LSG. METHODS: We conducted a prospective pilot study comparing ESG and LSG at two centers in Spain. We administered a standard test meal after an overnight fast, and collected blood samples before and after meal. We measured the levels of ghrelin, GLP-1, peptide-YY, insulin, leptin, and adiponectin. We evaluated the hormone profile and weight changes (%TBWL) at baseline and at 6 months after the procedure. RESULTS: Twenty-four patients were recruited (ESG-12, LSG-12). The baseline age, sex, BMI, and fasting hormone levels were similar between the groups. At 6-month post-ESG, there was a significant decline in the leptin levels. We found a trend towards a decrease in insulin levels and improvement in insulin secretory pattern. We did not observe any change in fasting ghrelin levels, GLP-1, and PYY. At 6 months, LSG induced a significant reduction in the ghrelin, and leptin levels, and increase in peptide-YY, and adiponectin levels, respectively. A trend towards an increase in GLP-1 level was noted. However, no change in insulin was observed. LSG achieved greater %TBWL (24.4 vs. 13.3, p < 0.001) and significantly change in ghrelin, PYY, and adiponectin levels at 6 months compared to ESG. CONCLUSION: ESG induced gut hormone changes differently as compared to LSG. ESG prevented a compensatory rise in ghrelin and promoted beneficial changes in the insulin secretory pattern with weight loss.

Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study.

INTRODUCTION: Endoscopic gastroplasty and gastric volume reduction techniques have been shown to achieve significant weight loss and improvement in comorbid conditions. The objective of this study is to assess the feasibility and safety of a novel fully automated, operator-independent endoscopic suturing system (EndoZip™) for minimally invasive treatment of obesity. DESIGN: Single-center pilot feasibility study. PATIENTS: Eleven patients with a body mass index (BMI) of 30 to 40 kg/m2 with or without obesity-associated comorbidity. INTERVENTIONS: Gastric volume reduction with EndoZip™ system. MAIN OUTCOME MEASUREMENTS: Primary outcome was to assess the technical feasibility and safety. The secondary outcome was to determine %total body weight loss (TBWL) and %excess weight loss (EWL) at 6 months. RESULTS: The mean ± SD age was 42.7 ± 5.6 years, and the mean ± SD BMI was 36.9 ± 2.8 kg/m2. A majority (64%) were men. The procedure was technically successful (100%) in all patients. A median of 3 (range, 2-4) full-thickness sutures were placed, and the mean procedure time was 54.6 ± 23.9 (23-100) min. No immediate complications occurred, and all were discharged in 24 h. One patient developed respiratory infection 3 days after the procedure and required hospitalization. The infection was mild and resolved with antibiotic treatment. At 6-month follow-up, the mean ± SD TBWL, %TBWL, and %EWL were 17.8 ± 6.7 kg, 16.2 ± 6.0%, and 54.3 ± 28.4%, respectively (p < 0.001). LIMITATIONS: Limited number of patients. CONCLUSION: Our first-in-human study showed that the Endozip™ device could be safely used for the treatment of obesity. The early weight loss results are promising. An extended feasibility study on a larger sample size is being planned (Clinicaltrials.gov. NCT03472196).