A comparison of novice and experienced physicians performing hysteroscopic sterilization: an analysis of an FDA-mandated trial

Objective: To assess the placement rates for experienced users versus newly trained physicians using the new ESS 305 delivery catheter for the Essure microinsert hysteroscopic sterilization system. Design: Multicenter prospective cohort study. Setting: Seventy-six sites throughout the U.S. comprising community hospitals, teaching institutions, surgery centers, and office-based practices. Patient(s): A total of 578 women seeking hysteroscopic sterilization. Intervention(s): Hysteroscopic sterilization with the ESS 305 device by either experienced or novice physicians. Main Outcome Measure(s): Successful bilateral placement of the Essure 305 device. Result(s): A total of 625 patients were recruited with 578 eligible cases performed by 37 newly trained and 39 experienced physicians: 562/578 (97.2%) overall had successful placement, with 98% successful placement rate versus 96.1% for experienced versus novice physicians, respectively. Mean procedural time was 9 minutes (±7 SD), with experienced physicians completing it on average quicker at 7.9 minutes (±5.8 SD) and novices completing it in 10.7 minutes (±8.3 SD). There was no significant association between successful placement with patient characteristics such as body mass index, surgical history, parity, or prior vaginal deliveries observed. Conclusion(s): The Essure procedure can be performed quickly and safely with high bilateral placement rates regardless of physician experience or patient characteristics.