Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial.

ABSTRACT:

Study objective

To report 36-month follow-up of a pivotal trial that evaluated the safety and effectiveness of the AEGEA Water Vapor System for the treatment of heavy menstrual bleeding (HMB) secondary to Abnormal Uterine Bleeding due to Endometrial disorders or Leiomyomata (AUB-E and AUB-L).

Methods

A prospective, multicenter, single-arm clinical trial at 14 sites in the US, Canada, Mexico, and the Netherlands. Inclusion criteria included a Pictorial Blood Loss Assessment (PBLAC, Higham) score ≥150 and allowed treatment of subjects with leiomyomata classified by the International Federation of Gynecology and Obstetrics (FIGO) Types 2-6 up to 4 cm in diameter, a uterine cavity up to 12 cm in length (uterine sound), Essure^® contraceptive inserts and/or prior cesare

SUBMITTER: Leyland N 

PROVIDER: S-EPMC7882459 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature