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

Completed · Not applicable

Conditions studied: Contraception

In brief

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

Key facts

Study ID

NCT03127722

Run by

Bayer

People needed

990

Starts

2017-05-03

Expected to finish

2024-12-31

Last updated by the study team

2026-05-22

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• 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
• New Horizons Women's Care — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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