A Prospective, Multicenter, Pivotal Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor Endometrial Ablation System.

Study Objective: To evaluate the safety and effectiveness of the AEGEA Vapor System (Aegea Medical System, Menlo Park, CA) for the treatment of heavy menstrual bleeding (HMB).

Design: A prospective, multicenter, single-arm, open-label, clinical trial. Follow-up assessments were conducted at 24 hours; 2 weeks; and 3, 6, and 12 months after the endometrial ablation procedure (Canadian Task Force Classification II-1).

Global endometrial ablation in the presence of essure® microinserts.

Abnormal uterine bleeding (AUB) affects 30% of women at some time during their reproductive years and is one of the most common reasons a woman sees a gynecologist. Many women are turning to endometrial ablation to manage their AUB. This article reviews the data relating to the available endometrial ablation techniques performed with hysteroscopic sterilization, and focuses on data from patients who had Essure® (Conceptus, San Carlos, CA) coils placed prior to performance of endometrial ablation.

Efficacy of a novel educational curriculum using a simulation laboratory on resident performance of hysteroscopic sterilization.

Objective: To assess whether a novel educational curriculum using a simulation teaching laboratory improves resident knowledge, comfort with, and surgical performance of hysteroscopic sterilization.

Design: An educational prospective, pretest/posttest study.

Setting: The Montefiore Institute of Minimally Invasive Surgery Laboratory.

A summary of reported pregnancies after hysteroscopic sterilization.

The purpose of this article is to describe 64 unintended pregnancies reported by patients who had undergone hysteroscopic sterilization and to provide recommendations for avoiding post-procedure pregnancies. Sixty-four pregnancies out of an estimated 50,000 procedures were reported to the device manufacturer from 1997 through December 2005. Most occurred in patients without appropriate follow-up.

Prospective analysis of office-based hysteroscopic sterilization.

Study Objectives: To evaluate the efficacy of performing the Essure hysteroscopic sterilization in an office-based setting.

Design: Prospective, longitudinal analysis (Canadian Task Force classification II-3).

Setting: University out-patient office.

Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis.

Study Objective: To evaluate the actual cost difference in performing Essure hysteroscopic sterilization in the office compared with ambulatory surgery using laparoscopic sterilization in the operating room.

Design: Cost-comparison analysis (Canadian Task Force classification III).

Setting: University hospital and affiliated outpatient office.