Trial Condition(s):

Contraception

Study to assess outcomes in women undergoing either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization

Bayer Identifier:

18894

ClinicalTrials.gov Identifier:

NCT03127722

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
990
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

New Horizons Women's Care

Chandler, United States, 85224

Status
Active, not recruiting
 
Locations

Visions Clinical Research - Tucson

Tucson, United States, 85712

Status
Active, not recruiting
 
Locations

Brown Stone Clinical Trials, LLC

Irving, United States, 75061

Status
Active, not recruiting
 
Locations

Southeast Texas Family Planning and Cancer Screening

Houston, United States, 77074

Status
Completed
 
Locations

Office of Dr. Cindy Basinski, LLC

Newburgh, United States, 47630

Status
Active, not recruiting
 
Locations

Columbus OB-GYN/Radiant Research

Columbus, United States, 43213

Status
Active, not recruiting
 
Locations

Complete Healthcare for Women, Inc.

Columbus, United States, 43231

Status
Active, not recruiting
 
Locations

Women's Integrated Health Care, PC

Grand Blanc, United States, 48439

Status
Active, not recruiting
 
Locations

Women's Health Advantage

Fort Wayne, United States, 46825

Status
Active, not recruiting
 
Locations

University of Tennessee Medical Center

Knoxville, United States, 37920

Status
Active, not recruiting
 
Locations

Horizon Research Group of Opelousas, LLC

Eunice, United States, 70535

Status
Active, not recruiting
 
Locations

OB-GYN Centre of Excellence

Chattanooga, United States, 37404

Status
Active, not recruiting
 
Locations

Tufts Medical Center

Boston, United States, 02111

Status
Active, not recruiting
 
Locations

Women's Health Alliance

Raleigh, United States, 27607

Status
Active, not recruiting
 
Locations

Amy Brenner, MD & Associates, LLC

Mason, United States, 45040

Status
Active, not recruiting
 
Locations

John H Stroger Jr. Hospital of Cook County

Chicago, United States, 60612

Status
Active, not recruiting
 
Locations

Women's Health Care Group of PA

Pottstown, United States, 19464

Status
Active, not recruiting
 
Locations

MetroHealth Medical Center

Cleveland, United States, 44109-1998

Status
Active, not recruiting
 
Locations

Women's Health Care, PC

Newburgh, United States, 47630

Status
Active, not recruiting
 
Locations

Brown Stone Clinical Trials, LLC

Irving, United States, 75061

Status
Completed
 
Locations

The Woman's Hospital of Texas

Houston, United States, 77054

Status
Completed
 
Locations

Wake Forest Baptist Health

Winston-Salem, United States, 27157-1009

Status
Active, not recruiting
 
Locations

Jersey Shore University Medical Center

Neptune, United States, 07753

Status
Active, not recruiting
 
Locations

Oklahoma University

Oklahoma City, United States, 73104

Status
Completed
 
Locations

University of Kentucky Albert B. Chandler Hospital

Lexington, United States, 40536-0001

Status
Completed
 
Locations

Wright State Physicians Health Center

Dayton, United States, 45405-4534

Status
Active, not recruiting
 
Locations

Columbia University Medical Center

New York, United States, 10032

Status
Active, not recruiting
 
Locations

IU Health University Hospital

Indianapolis, United States, 46202

Status
Completed
 
Locations

AC Clinical Research

Tiffin, United States, 44883-2820

Status
Active, not recruiting
 
Locations

Reading Hospital

West Reading, United States, 19611

Status
Active, not recruiting
 
Locations

United Clinical Research

Huntington Beach, United States, 90255

Status
Active, not recruiting
 
Locations

The Women's Health Group, P.C.

Thornton, United States, 80229-4388

Status
Active, not recruiting
 
Locations

St. Luke's Hospital - Allentown Campus

Allentown, United States, 18104-9701

Status
Completed
 
Locations

Precision Trials, AZ, LLC

Phoenix, United States, 85032

Status
Active, not recruiting
 
Locations

Ben Taub General Hospital

Houston, United States, 77030

Status
Completed
 
Locations

HWC Women’s Research Center

Englewood, United States, 45322

Status
Active, not recruiting
 
Locations

HillTop Obstetrics & Gynecology

Franklin, United States, 45005-2593

Status
Active, not recruiting
 
Locations

Tanner Clinic

Layton, United States, 84041-8803

Status
Active, not recruiting
 
Locations

Physician Care Clinical Research

Sarasota, United States, 34239

Status
Completed
 
Locations

Tidewater Clinical Research, Inc.

Virginia Beach, United States, 23456

Status
Active, not recruiting
 
Locations

Women & Infants Hospital (OGCC)

Providence, United States, 02905

Status
Active, not recruiting
 
Locations

Seven Hills Women's Health Centers

Cincinnati, United States, 45242

Status
Active, not recruiting
 
Locations

Palmetto Clinical Research (PCR)

Charleston, United States, 29406-9126

Status
Active, not recruiting
 
Locations

Unified Women's Clinical Research

Winston Salem, United States, 27103-1749

Status
Active, not recruiting
 
Locations

Eclipse Clinical Research

Tuscon, United States, 85745-2696

Status
Active, not recruiting
 
Locations

Ohio State University

Columbus, United States, 43210

Status
Active, not recruiting
 
Locations

Clinical Research Prime, LLLP

Idaho Falls, United States, 83402-3344

Status
Active, not recruiting
 
Locations

Unified Women's Clinical Research, LLC

Greensboro, United States, 27401-1207

Status
Active, not recruiting
 
Locations

Mid-Atlantic Permanente Research Institute

Rockville, United States, 20852

Status
Active, not recruiting
 
Locations

Baptist Health Center for Clinical Research

Little Rock, United States, 72205-6325

Status
Active, not recruiting
 
Locations

Women's Healthcare Associates, LLC - Tualatin

Pleasant Grove, United States, 84062-4097

Status
Active, not recruiting
 
Locations

Orange Coast Women's Medical Group - Laguna Hills Office

Laguna Hills, United States, 92653

Status
Active, not recruiting
 
Locations

Physicians Research Options, LLC

Lakewood, United States, 80228

Status
Active, not recruiting
 
Locations

Altus Research

Lake Worth, United States, 33461

Status
Completed
 
Locations

M & O Clinical Research, LLC

Ft. Lauderdale, United States, 33316

Status
Active, not recruiting
 
Locations

Universal Axon Clinical Research

Miami, United States, 33166

Status
Active, not recruiting
 
Locations

Oregon Health and Science University

Portland, United States, 97239

Status
Active, not recruiting
 
Locations

The Iowa Clinic, PC

West Des Moines, United States, 50266-8289

Status
Active, not recruiting
 

Trial Design