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



Status:Recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:21 - Any
Updated:3/28/2019
Start Date:May 3, 2017
End Date:December 31, 2024
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+) 1-888-8422937

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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

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.
We found this trial at
63
sites
Sarasota, Florida 34321
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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Oklahoma City, Oklahoma 73104
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Allentown, Pennsylvania 18104
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Chandler, Arizona 85226
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Charleston, South Carolina 29406
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Chattanooga, Tennessee 37404
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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10506 Montgomery Road
Cincinnati, Ohio 45242
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Cincinnati, OH
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Columbus, Ohio 43213
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Columbus, Ohio 43231
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Detroit, Michigan 48201
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Fort Lauderdale, Florida 33316
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Fort Wayne, Indiana 46825
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200 Medical Center Drive
Franklin, Ohio 45005
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1595 Genesys Parkway
Grand Blanc, Michigan 48439
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Greensboro, North Carolina 27408
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6671 Southwest Freeway
Houston, Texas 77074
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Houston, Texas 77054
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1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
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Huntington Beach, California 90255
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Idaho Falls, Idaho 83402
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Indianapolis, Indiana 46202
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2505 Texas Drive
Irving, Texas 75061
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Knoxville, Tennessee 37920
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255 Union Boulevard
Lakewood, Colorado 80228
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Lansing, Michigan 48912
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Layton, Utah 84041
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Little Rock, Arkansas 72205
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Loxahatchee Groves, Florida 33470
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6413 Thornberry Court
Mason, Ohio 45040
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Miami, Florida 33166
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Neptune, New Jersey 07754
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newburgh, Indiana 47630
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4199 Gateway Boulevard
Newburgh, Indiana 47630
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Panama City, Florida 32405
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Phoenix, Arizona 85032
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1597 Medical Drive
Pottstown, Pennsylvania 19464
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Providence, Rhode Island 02905
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4414 Lake Boone Trail
Raleigh, North Carolina 27607
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Richmond, Virginia 23233
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Rockville, Maryland 20852
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Thornton, Colorado 80229
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Tiffin, Ohio 44883
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Tucson, Arizona 85721
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Tucson, Arizona 85745
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Virginia Beach, Virginia 23456
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West Des Moines, Iowa 50266
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300 South 6th Avenue
West Reading, Pennsylvania 19611
(610) 988-8000
Reading Hospital At Reading Health System, advancing your health and wellness is our mission. When...
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Winston-Salem, North Carolina 27157
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Winston-Salem, North Carolina 27103
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