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

NCT03127722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 990

Last updated 2026-05-22

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-03
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03127722 on ClinicalTrials.gov