NCT03127722

Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

An Open-label, Non-randomized, Prospective Observational Cohort Study to Assess Post-procedural Outcomes in Two Cohorts of Women Who Chose to Undergo Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 990 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including: * Pelvic and/or lower abdominal pain * Abnormal uterine bleeding * Surgical intervention (including "insert removal" and hysterectomy) * Allergic, hypersensitivity, or autoimmune-like reactions

Conditions

• Contraception

Interventions

Type	Name	Description
PROCEDURE	Blood draw	Decision for either treatment will be based upon clinical practice and physician/patient counseling. In addition of routine care practice, blood draws will be performed at baseline, 12 months and 60 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization.
DEVICE	ESSURE (BAY1454032)	Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
PROCEDURE	Laparoscopic tubal sterilization	Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.

Timeline

• Start date: 2017-05-03
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2017-04-25
• Last updated: 2025-01-08

Locations

57 sites across 1 country: United States

Regulatory

• FDA-regulated device study