2521 Post-Market Surgeon Safety Outcomes and Experience Performing Laparoscopic Ultrasound-Guided Radiofrequency Ablation using the Acessa™ System

Abstract

Study Objective 1) Evaluate intraoperative and near-term safety outcomes following laparoscopic radiofrequency ablation of fibroids (Lap-RFA) performed by gynecologic surgeons new to the procedure, using the Acessa™ system (Acessa Health, Austin, TX, USA). 2) Compare observed complication rates with those from the pivotal study. Design Post-market, prospective, single-arm, multicenter analysis; 4-8 weeks’ follow-up. Setting Community and university hospitals in the U.S. and Canada. Patients or Participants Surgeons (N=29) with varying levels of laparoscopic surgery experience participating in the ongoing, multinational Treatment Results of Uterine Sparing Technologies (TRUST) randomized clinical trial. Patients were premenopausal women (N=110), aged ≥18 years, enrolled as either run-in patients or randomized to the TRUST Lap-RFA arm. Interventions During run-in, surgeons received proctored Lap-RFA training. Following training, and after performing ≥2 procedures, surgeons provided feedback using a standardized form. Measurements and Main Results The primary endpoints were acute intraoperative and serious near-term postoperative complications, defined as occurring Conclusion There were no significant differences in safety outcomes when comparing the pre- and post-market studies. Minimally invasive gynecologic surgeons can safely learn the Lap-RFA procedure with acceptable outcomes after 2-3 proctored cases.