At a glance
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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
In Brief
A clinical study evaluating Blood draw, ESSURE (BAY1454032), and 1 other intervention for Contraception. Completed, enrolled 990 participants across 57 sites.
Detailed 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
Study Details
Timeline
Interventions
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.
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.