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

NCT03127722 | Completed Results DMC FDA Device

• 1 other identifier: 18894
• Study Type: interventional
• Target: 990
• Locations: 1 country
• Sites: 57

Brief 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

Outcome Measures

Primary Outcomes (5)

• Proportion of Subjects Reporting AEs of Chronic Lower Abdominal and/or Pelvic Pain After Insertion of Essure System or After Laparoscopic Tubal Sterilization

  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

  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

  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

  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

  Up to 60 months

Study Arms (2)

ESSURE (BAY1454032)

EXPERIMENTAL

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; Device: ESSURE (BAY1454032)

Laparoscopic tubal sterilization

ACTIVE COMPARATOR

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

Procedure: Blood draw; Procedure: Laparoscopic tubal sterilization

Interventions

Laparoscopic tubal sterilization PROCEDURE

Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.

Laparoscopic tubal sterilization

Blood draw PROCEDURE

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.

ESSURE (BAY1454032); Laparoscopic tubal sterilization

ESSURE (BAY1454032) DEVICE

Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.

ESSURE (BAY1454032)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (57)

New Horizons Women's Care

Chandler, Arizona, 85224, United States

Location

Precision Trials, AZ, LLC

Phoenix, Arizona, 85032, United States

Location

Visions Clinical Research - Tucson

Tucson, Arizona, 85712, United States

Location

Eclipse Clinical Research

Tucson, Arizona, 85745-2696, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205-6325, United States

Location

United Clinical Research

Huntington Beach, California, 90255, United States

Location

Orange Coast Women's Medical Group - Laguna Hills Office

Laguna Hills, California, 92653, United States

Location

Physicians Research Options, LLC

Lakewood, Colorado, 80228, United States

Location

The Women's Health Group, P.C.

Thornton, Colorado, 80229-4388, United States

Location

M & O Clinical Research, LLC

Fort Lauderdale, Florida, 33316, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Universal Axon Clinical Research

Miami, Florida, 33166, United States

Location

Physician Care Clinical Research

Sarasota, Florida, 34239, United States

Location

Clinical Research Prime, LLLP

Idaho Falls, Idaho, 83402-3344, United States

Location

John H Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Office of Dr. Cindy Basinski, LLC

Newburgh, Indiana, 47630, United States

Location

Women's Health Care, PC

Newburgh, Indiana, 47630, United States

Location

The Iowa Clinic, PC

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

Location

University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, 40536-0001, United States

Location

Horizon Research Group of Opelousas, LLC

Eunice, Louisiana, 70535, United States

Location

Mid-Atlantic Permanente Research Institute

Rockville, Maryland, 20852, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Women's Integrated Health Care, PC

Grand Blanc, Michigan, 48439, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Unified Women's Clinical Research, LLC

Greensboro, North Carolina, 27401-1207, United States

Location

Women's Health Alliance

Raleigh, North Carolina, 27607, United States

Location

Unified Women's Clinical Research

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

Location

Wake Forest Baptist Health

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

Location

Seven Hills Women's Health Centers

Cincinnati, Ohio, 45242, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109-1998, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Columbus OB-GYN/Radiant Research

Columbus, Ohio, 43213, United States

Location

Complete Healthcare for Women, Inc.

Columbus, Ohio, 43231, United States

Location

Wright State Physicians Health Center

Dayton, Ohio, 45405-4534, United States

Location

HWC Women's Research Center

Englewood, Ohio, 45322, United States

Location

HillTop Obstetrics & Gynecology

Franklin, Ohio, 45005-2593, United States

Location

Amy Brenner, MD & Associates, LLC

Mason, Ohio, 45040, United States

Location

AC Clinical Research

Tiffin, Ohio, 44883-2820, United States

Location

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

St. Luke's Hospital - Allentown Campus

Allentown, Pennsylvania, 18104-9701, United States

Location

Women's Health Care Group of PA

Pottstown, Pennsylvania, 19464, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Women & Infants Hospital (OGCC)

Providence, Rhode Island, 02905, United States

Location

Palmetto Clinical Research (PCR)

Charleston, South Carolina, 29406-9126, United States

Location

OB-GYN Centre of Excellence

Chattanooga, Tennessee, 37404, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

The Woman's Hospital of Texas

Houston, Texas, 77054, United States

Location

Southeast Texas Family Planning and Cancer Screening

Houston, Texas, 77074, United States

Location

Brown Stone Clinical Trials, LLC

Irving, Texas, 75061, United States

Location

Tanner Clinic

Layton, Utah, 84041-8803, United States

Location

Women's Healthcare Associates, LLC - Tualatin

Pleasant Grove, Utah, 84062-4097, United States

Location

Tidewater Clinical Research, Inc.

Virginia Beach, Virginia, 23456, United States

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

This study is descriptive and not designed to detect statistical differences. The analyses are exploratory. Physicians and patients should consider the totality of scientific evidence regarding Essure's safety and effectiveness when making clinical decisions. It is hypothesized that the observed outcomes may align with the known benefit-risk profile of Essure and historical data for laparoscopic tubal sterilization (LTS).

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+)1-888-84 22937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: April 25, 2017
• Study Start: May 3, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (57)