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Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
Sponsor: Bayer
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
Official title: 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
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2017-05-03
Completion Date
2024-12-31
Last Updated
2026-05-22
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (57)
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