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

April 30, 2026 updated by: Bayer

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
990

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • New Horizons Women's Care
      • Phoenix, Arizona, United States, 85032
        • Precision Trials, AZ, LLC
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research - Tucson
      • Tucson, Arizona, United States, 85745-2696
        • Eclipse Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-6325
        • Baptist Health Center for Clinical Research
    • California
      • Huntington Beach, California, United States, 90255
        • United Clinical Research
      • Laguna Hills, California, United States, 92653
        • Orange Coast Women's Medical Group - Laguna Hills Office
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Physicians Research Options, LLC
      • Thornton, Colorado, United States, 80229-4388
        • The Women's Health Group, P.C.
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • M & O Clinical Research, LLC
      • Lake Worth, Florida, United States, 33461
        • Altus Research
      • Miami, Florida, United States, 33166
        • Universal Axon Clinical Research
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research
    • Idaho
      • Idaho Falls, Idaho, United States, 83402-3344
        • Clinical Research Prime, LLLP
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr. Hospital of Cook County
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Women's Health Advantage
      • Indianapolis, Indiana, United States, 46202
        • IU Health University Hospital
      • Newburgh, Indiana, United States, 47630
        • Office of Dr. Cindy Basinski, LLC
      • Newburgh, Indiana, United States, 47630
        • Women's Health Care, PC
    • Iowa
      • West Des Moines, Iowa, United States, 50266-8289
        • The Iowa Clinic, PC
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0001
        • University of Kentucky Albert B. Chandler Hospital
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group of Opelousas, LLC
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Mid-Atlantic Permanente Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Women's Integrated Health Care, PC
    • New Jersey
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore University Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401-1207
        • Unified Women's Clinical Research, LLC
      • Raleigh, North Carolina, United States, 27607
        • Women's Health Alliance
      • Winston-Salem, North Carolina, United States, 27103-1749
        • Unified Women's Clinical Research
      • Winston-Salem, North Carolina, United States, 27157-1009
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Seven Hills Women's Health Centers
      • Cleveland, Ohio, United States, 44109-1998
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Columbus, Ohio, United States, 43213
        • Columbus OB-GYN/Radiant Research
      • Columbus, Ohio, United States, 43231
        • Complete Healthcare for Women, Inc.
      • Dayton, Ohio, United States, 45405-4534
        • Wright State Physicians Health Center
      • Englewood, Ohio, United States, 45322
        • HWC Women's Research Center
      • Franklin, Ohio, United States, 45005-2593
        • HillTop Obstetrics & Gynecology
      • Mason, Ohio, United States, 45040
        • Amy Brenner, MD & Associates, LLC
      • Tiffin, Ohio, United States, 44883-2820
        • AC Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104-9701
        • St. Luke's Hospital - Allentown Campus
      • Pottstown, Pennsylvania, United States, 19464
        • Women's Health Care Group of PA
      • West Reading, Pennsylvania, United States, 19611
        • Reading Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital (OGCC)
    • South Carolina
      • Charleston, South Carolina, United States, 29406-9126
        • Palmetto Clinical Research (PCR)
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • OB-GYN Centre of Excellence
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Texas
      • Houston, Texas, United States, 77054
        • The Woman's Hospital of Texas
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital
      • Houston, Texas, United States, 77074
        • Southeast Texas Family Planning and Cancer Screening
      • Irving, Texas, United States, 75061
        • Brown Stone Clinical Trials, LLC
    • Utah
      • Layton, Utah, United States, 84041-8803
        • Tanner Clinic
      • Pleasant Grove, Utah, United States, 84062-4097
        • Women's Healthcare Associates, LLC - Tualatin
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Tidewater Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects who are at least 21 years of age;
  • Subjects of all weights will be included;
  • Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling.

  • For the Essure group only:

    • Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU;

  • For the laparoscopic tubal sterilization group only:

    • Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care.

Exclusion Criteria:

  • Subjects who are post-menopausal;
  • Subjects suspected of being or confirmed pregnant;
  • Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled procedure;
  • Subjects uncertain about ending fertility;
  • Subjects with an active upper or lower genital tract infection;
  • Subjects with gynecologic malignancy (suspected or known);
  • Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic);
  • Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization;
  • Subjects with unexplained vaginal bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ESSURE (BAY1454032)
Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU. Subject willing to use alternative contraception for at least 3 months post-Essure placement procedure, until a satisfactory Essure Confirmation Test is documented.
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.
Active Comparator: Laparoscopic tubal sterilization
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization
Time Frame: Up to 60 months
The proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after insertion of Essure System compared to the proportion of subjects reporting AEs of chronic lower abdominal and / or pelvic pain after laparoscopic tubal sterilization. Statistical analyses were exploratory and descriptive in nature and no confirmatory hypothesis testing was intended to be performed; p-values were to be interpreted as a metric for uncertainty (note: no analysis included in this final analysis provides p-values). Therefore, no adjustment for multiplicity was necessary. All endpoints and variables were analyzed by descriptive statistical methods.
Up to 60 months
Bleeding: The Proportion of Subjects Reporting AEs of Abnormal Uterine Bleeding (AUB) After Insertion of Essure System Compared to the Proportion of Subjects Reporting AEs of AUB After Laparoscopic Tubal Sterilization
Time Frame: Up to 60 months
Incidence of new onset or worsening abnormal bleeding events was based on AE reporting. If a potential bleeding AE was reported at a scheduled visit or if the subject spontaneously reports such an event to the site at some other time, the event was to be evaluated per standard AE assessment. If during the course of a scheduled PRO administration the subject indicated that she experienced abnormal bleeding that reached a preset threshold on the questionnaire, the investigator was alerted and instructed to investigate this finding in order to determine whether or not an AE occurred.
Up to 60 months
Proportion of Subjects With Reported Allergic/Hypersensitivity Reactions
Time Frame: Up to 60 months
For potential allergic/hypersensitivity reactions, investigators were instructed that an evaluation was to be performed in subjects who presented with symptoms that could have possibly been related to an inflammatory reaction. After the evaluation of the subject was complete, regardless of the investigator's assessment as to whether or not a hypersensitivity/allergic reaction had occurred, all information was to be forwarded to the Adjudication Committee in a blinded fashion. Final determination of whether or not a hypersensitivity/allergic event had occurred was based on the determination of this committee.
Up to 60 months
Proportion of Subjects With Newly Diagnosed or Worsening Autoimmune Disorders
Time Frame: Up to 60 months

Any subject presenting with symptoms indicating a potential autoimmune disorder was to be evaluated per standard medical practice. All effort was to be made to obtain records of any diagnostic workup conducted by outside physicians. NiLPT, chromium LPT, serum or plasma nickel level, and serum or plasma titanium level and serum inflammatory cytokines samples were also to be drawn by the study site. An appropriate human leukocyte antigen (HLA) panel was to be run on previously obtained baseline samples if sufficient sample existed.

After the evaluation of the subject was complete, all information was to be forwarded to the adjudication committee in a blinded fashion, regardless of investigator's assessment as to whether or not an autoimmune disorder existed. Final determination of whether or not an autoimmune disorder had occurred was based on the determination of this committee.
Up to 60 months
Proportion of Subjects Undergoing Invasive Gynecologic Surgery After Essure Placement (Excluding Second Placement Attempts), Including Essure Removal Compared to Subjects Undergoing Invasive Gynecologic Surgery After Laparoscopic Tubal Sterilization
Time Frame: Up to 60 months
Up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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