Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
NCT ID: NCT03127722
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
990 participants
INTERVENTIONAL
2017-05-03
2024-12-31
Brief Summary
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* Pelvic and/or lower abdominal pain
* Abnormal uterine bleeding
* Surgical intervention (including "insert removal" and hysterectomy)
* Allergic, hypersensitivity, or autoimmune-like reactions
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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.
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.
Laparoscopic tubal sterilization
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
21 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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New Horizons Women's Care
Chandler, Arizona, United States
Precision Trials, AZ, LLC
Phoenix, Arizona, United States
Visions Clinical Research - Tucson
Tucson, Arizona, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
United Clinical Research
Huntington Beach, California, United States
Orange Coast Women's Medical Group - Laguna Hills Office
Laguna Hills, California, United States
Physicians Research Options, LLC
Lakewood, Colorado, United States
The Women's Health Group, P.C.
Thornton, Colorado, United States
M & O Clinical Research, LLC
Fort Lauderdale, Florida, United States
Altus Research
Lake Worth, Florida, United States
Universal Axon Clinical Research
Miami, Florida, United States
Physician Care Clinical Research
Sarasota, Florida, United States
Clinical Research Prime, LLLP
Idaho Falls, Idaho, United States
John H Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
IU Health University Hospital
Indianapolis, Indiana, United States
Office of Dr. Cindy Basinski, LLC
Newburgh, Indiana, United States
Women's Health Care, PC
Newburgh, Indiana, United States
The Iowa Clinic, PC
West Des Moines, Iowa, United States
University of Kentucky Albert B. Chandler Hospital
Lexington, Kentucky, United States
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, United States
Mid-Atlantic Permanente Research Institute
Rockville, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Women's Integrated Health Care, PC
Grand Blanc, Michigan, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Unified Women's Clinical Research, LLC
Greensboro, North Carolina, United States
Women's Health Alliance
Raleigh, North Carolina, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Seven Hills Women's Health Centers
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Columbus OB-GYN/Radiant Research
Columbus, Ohio, United States
Complete Healthcare for Women, Inc.
Columbus, Ohio, United States
Wright State Physicians Health Center
Dayton, Ohio, United States
HWC Women's Research Center
Englewood, Ohio, United States
HillTop Obstetrics & Gynecology
Franklin, Ohio, United States
Amy Brenner, MD & Associates, LLC
Mason, Ohio, United States
AC Clinical Research
Tiffin, Ohio, United States
Oklahoma University
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
St. Luke's Hospital - Allentown Campus
Allentown, Pennsylvania, United States
Women's Health Care Group of PA
Pottstown, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Women & Infants Hospital (OGCC)
Providence, Rhode Island, United States
Palmetto Clinical Research (PCR)
Charleston, South Carolina, United States
OB-GYN Centre of Excellence
Chattanooga, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Ben Taub General Hospital
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
Southeast Texas Family Planning and Cancer Screening
Houston, Texas, United States
Brown Stone Clinical Trials, LLC
Irving, Texas, United States
Tanner Clinic
Layton, Utah, United States
Women's Healthcare Associates, LLC - Tualatin
Pleasant Grove, Utah, United States
Tidewater Clinical Research, Inc.
Virginia Beach, Virginia, United States
Countries
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Related Links
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Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
Other Identifiers
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18894
Identifier Type: -
Identifier Source: org_study_id
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