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Essure vs. laparoscopic sterilization: which has fewer side effects?

NCT ID NCT03127722

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 990 women who chose either Essure or laparoscopic sterilization to compare rates of pain, abnormal bleeding, allergic reactions, and the need for further surgery. Researchers collected blood samples and tracked health outcomes over time. The goal was to better understand the risks of each procedure, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

990 people

The number who actually took part.

Started

May 2017

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contraception

Contacts and locations

Locations

  • AC Clinical Research

    Tiffin, Ohio, 44883-2820, United States

  • Altus Research

    Lake Worth, Florida, 33461, United States

  • Amy Brenner, MD & Associates, LLC

    Mason, Ohio, 45040, United States

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205-6325, United States

  • Ben Taub General Hospital

    Houston, Texas, 77030, United States

  • Brown Stone Clinical Trials, LLC

    Irving, Texas, 75061, United States

  • Clinical Research Prime, LLLP

    Idaho Falls, Idaho, 83402-3344, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Columbus OB-GYN/Radiant Research

    Columbus, Ohio, 43213, United States

  • Complete Healthcare for Women, Inc.

    Columbus, Ohio, 43231, United States

  • Eclipse Clinical Research

    Tucson, Arizona, 85745-2696, United States

  • HWC Women's Research Center

    Englewood, Ohio, 45322, United States

  • HillTop Obstetrics & Gynecology

    Franklin, Ohio, 45005-2593, United States

  • Horizon Research Group of Opelousas, LLC

    Eunice, Louisiana, 70535, United States

  • IU Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753, United States

  • John H Stroger Jr. Hospital of Cook County

    Chicago, Illinois, 60612, United States

  • M & O Clinical Research, LLC

    Fort Lauderdale, Florida, 33316, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109-1998, United States

  • Mid-Atlantic Permanente Research Institute

    Rockville, Maryland, 20852, United States

  • New Horizons Women's Care

    Chandler, Arizona, 85224, United States

  • OB-GYN Centre of Excellence

    Chattanooga, Tennessee, 37404, United States

  • Office of Dr. Cindy Basinski, LLC

    Newburgh, Indiana, 47630, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Oklahoma University

    Oklahoma City, Oklahoma, 73104, United States

  • Orange Coast Women's Medical Group - Laguna Hills Office

    Laguna Hills, California, 92653, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Palmetto Clinical Research (PCR)

    Charleston, South Carolina, 29406-9126, United States

  • Physician Care Clinical Research

    Sarasota, Florida, 34239, United States

  • Physicians Research Options, LLC

    Lakewood, Colorado, 80228, United States

  • Precision Trials, AZ, LLC

    Phoenix, Arizona, 85032, United States

  • Reading Hospital

    West Reading, Pennsylvania, 19611, United States

  • Seven Hills Women's Health Centers

    Cincinnati, Ohio, 45242, United States

  • Southeast Texas Family Planning and Cancer Screening

    Houston, Texas, 77074, United States

  • St. Luke's Hospital - Allentown Campus

    Allentown, Pennsylvania, 18104-9701, United States

  • Tanner Clinic

    Layton, Utah, 84041-8803, United States

  • The Iowa Clinic, PC

    West Des Moines, Iowa, 50266-8289, United States

  • The Woman's Hospital of Texas

    Houston, Texas, 77054, United States

  • The Women's Health Group, P.C.

    Thornton, Colorado, 80229-4388, United States

  • Tidewater Clinical Research, Inc.

    Virginia Beach, Virginia, 23456, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Unified Women's Clinical Research

    Winston-Salem, North Carolina, 27103-1749, United States

  • Unified Women's Clinical Research, LLC

    Greensboro, North Carolina, 27401-1207, United States

  • United Clinical Research

    Huntington Beach, California, 90255, United States

  • Universal Axon Clinical Research

    Miami, Florida, 33166, United States

  • University of Kentucky Albert B. Chandler Hospital

    Lexington, Kentucky, 40536-0001, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • Visions Clinical Research - Tucson

    Tucson, Arizona, 85712, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157-1009, United States

  • Women & Infants Hospital (OGCC)

    Providence, Rhode Island, 02905, United States

  • Women's Health Advantage

    Fort Wayne, Indiana, 46825, United States

  • Women's Health Alliance

    Raleigh, North Carolina, 27607, United States

  • Women's Health Care Group of PA

    Pottstown, Pennsylvania, 19464, United States

  • Women's Health Care, PC

    Newburgh, Indiana, 47630, United States

  • Women's Healthcare Associates, LLC - Tualatin

    Pleasant Grove, Utah, 84062-4097, United States

  • Women's Integrated Health Care, PC

    Grand Blanc, Michigan, 48439, United States

  • Wright State Physicians Health Center

    Dayton, Ohio, 45405-4534, United States

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