95: Advances in Hysteroscopic Sterilization: Report on 600 Patients Enrolled in the Adiana Ease Pivotal Trial

Abstract

To assess the safety and efficacy of innovative, permanent, transcervical sterilization (TCS) system. Multi-center, prospective trial with 4,000 women-months of follow up. Sixteen geographically diverse treatment facilities. Six hundred four parous, healthy reproductive-age women, at risk for pregnancy, and desiring permanent sterilization. Hysteroscopic sterilization with Adiana TCS System (Redwood City, CA, USA); 3 months alternative contraception; documented tubal occlusion by HSG; withdrawal of alternative contraception. After screening, 509 patients were brought to hysteroscopy. Four hundred ninety-nine patients had attempted catheter placement with bilateral success in 473 patients (94.8%). Six centers performed treatments solely in an office environment; 10 centers performed treatments in ambulatory surgery; two centers moved their treatments from the O.R. to the office as the study progressed. Oral or parenteral NSAIDs were routinely used. Local anesthesia without IV sedation was used in 48.8% of patients. Local anesthesia was supplemented with IV sedation in 51.2% of patients. Mean procedure time (“scope in to scope out”) was 12 minutes + 8 minutes. One pregnancy occurred in a re-treated patient relying on the device whose implant placement was subsequently determined to be unilateral. The observed one-year pregnancy prevention rate was 99.7%. There have been no serious device-related adverse events in the trial. These data suggest that the Adiana TCS System is easy to use, safe, and effective. Because the non-metallic implant remains fully outside the uterine cavity, advantages over other systems may include easier insertion and future access to intracavitary diagnostic or therapeutic interventions should they become necessary, possibly including IVF. Patient follow-up is ongoing.