A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

STUDY OBJECTIVE: To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women. DESIGN: Multicenter, randomized, controlled, international study (Canadian Task Force classification I). SETTING: Thirteen academic and private medical centers. PATIENTS: Premenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O). INTERVENTION: Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation. MEASUREMENTS AND MAIN RESULTS: At 1-year post-treatment, study success (alkaline hematin ≤80 mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1 minutes for Minerva and 17.2 minutes for rollerball. There were no intraoperative adverse events and/or complications reported. CONCLUSION: The results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures.