Study Objective: To assess the interaction between the trailing ends of a sterilization micro-insert extending into the uterine cavity and the surrounding uterine tissue environment over time.
Design: Multicenter, retrospective observational study (Canadian Task Force classification II-1).
Setting: Hospital-based clinical research centers.
Objective: To assess the compatibility of pregnancy after IVF and ET procedures with the presence of the Essure microinsert.
Design: Prospective, single-arm, clinical study (Canadian Task Force classification III).
Setting: Clinical research center.
Study Objective: To examine the reliability and practicality of performing office-based transvaginal ultrasound for determining the ease of locating the Essure hysteroscopic sterilization micro-insert and compare its usefulness against established radiologic evaluations.
Design: Prospective single-center, single-arm, clinical study (Canadian Task Force classification xx).
Setting: Hospital-based clinical research center.
J Am Assoc Gynecol Laparosc
August 2004
Study Objective: To assess the safety and placement effectiveness of a new delivery catheter for the Essure micro-insert hysteroscopic sterilization system.
Design: Prospective, multicenter, single-arm clinical study. (Canadian Task Force classification II-3).
Objective: To assess the safety, effectiveness, and reliability of a tubal occlusion microinsert for permanent contraception, as well as to document patient recovery from the placement procedure and overall patient satisfaction.
Methods: A cohort of 518 previously fertile women seeking sterilization participated in this prospective, phase III, international, multicenter trial. Microinsert placement was attempted in 507 women.
Background: Unlike laparoscopic surgery for interval tubal sterilization, a hysteroscopic approach obviates surgical incision and requires only local anaesthesia or intravenous sedation. The safety, tolerability and efficacy of an hysteroscopically placed micro-insert device was evaluated.
Methods: A cohort of 227 previously fertile women participated in this prospective international multicentre trial.