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

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Procedure: Blood draw; Device: ESSURE (BAY1454032); Procedure: Laparoscopic tubal sterilization

• Registration Number: NCT03127722
• Lead Sponsor: Bayer

Brief 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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
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Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-03-05
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Study Start: 2017-05-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 990

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESSURE (BAY1454032)	Blood draw	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.
ESSURE (BAY1454032)	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.
Laparoscopic tubal sterilization	Blood draw	Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care
Laparoscopic tubal sterilization	Laparoscopic tubal sterilization	Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care

Primary Outcome Measures

Name	Time	Method
Bleeding: The proportion of AEs of abnormal uterine bleeding (AUB) after insertion of Essure System compared to the proportion of AEs of AUB after laparoscopic tubal sterilization	Up to 60 months	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Patient reported outcomes for pain interference	Up to 60 months	Patient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Interference 8a´. Pain interference is assessed via questions and ranked across 5 levels from ´Not at all´ to ´Very much´.
Patient reported outcomes for centralized pain	At baseline	Assessed with the Fibromyalgia Survey Questionnaire
Patient reported outcomes on media sources for their medical decisioning	Up to 60 months	Assessed by Social Media questionnaire to elicit information about sources of influence on medical decisions.
Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilization	Up to 60 months	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Pain: The proportion of AEs of chronic lower abdominal and/or pelvic pain after insertion of Essure System compared to the proportion of AEs of chronic lower abdominal and/or pelvic pain after laparoscopic tubal sterilization	Up to 60 months	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Hypersensitivity / allergy / autoimmune disorders: The proportion of subjects with new onset or worsening allergic/hypersensitivity reactions and newly diagnosed or worsening autoimmune disorders in Essure vs laparoscopic tubal sterilization arms	Up to 60 months	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Proportion of subjects undergoing invasive gynecologic surgery after Essure placement (excluding second placement attempts), including Essure removal compared to subjects undergoing invasive gynecologic surgery after laparoscopic tubal sterilization	Up to 60 months	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
Patient reported outcomes for health status	Up to 60 months	Medical Outcomes Study Short Form-36
Patient reported outcomes for pain intensity	Up to 60 months	Patient-Reported Outcomes Measurement Information System (PROMIS) scale V1.0, form ´Pain Intensity 3a´. Pain intensity is assessed via questions and ranked across 5 levels from ´No pain´ to ´Very severe pain´.
Patient reported outcomes for bleeding by AMSS	Up to 60 months	Aberdeen Menorrhagia Severity Scale (AMSS) is used to characterize bleeding. AMSS is a questionaire consisting of 13 items giving a total score from 0 (least severe) to 42 points (most severe).
Patient reported outcomes for bleeding by intermenstrual bleeding questions	Up to 60 months	Two questions used to characterize intermenstrual bleeding.
Patient reported outcomes on adverse events from device reports	Up to 60 months	Assessed by questionnaires to actively solicit information on adverse events found in medical device reporting (MDR) reports with Essure and control potential bias in adverse event reporting.

Trial Locations

Locations (57)

Columbus OB-GYN/Radiant Research; 🇺🇸 Columbus, Ohio, United States

Complete Healthcare for Women, Inc.; 🇺🇸 Columbus, Ohio, United States

Universal Axon Clinical Research; 🇺🇸 Miami, Florida, United States

Altus Research; 🇺🇸 Lake Worth, Florida, United States

Southeast Texas Family Planning and Cancer Screening; 🇺🇸 Houston, Texas, United States

Precision Trials, AZ, LLC; 🇺🇸 Phoenix, Arizona, United States

Seven Hills Women's Health Centers; 🇺🇸 Cincinnati, Ohio, United States

Oklahoma University; 🇺🇸 Oklahoma City, Oklahoma, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Brown Stone Clinical Trials, LLC; 🇺🇸 Irving, Texas, United States

New Horizons Women's Care; 🇺🇸 Chandler, 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

Visions Clinical Research - Tucson; 🇺🇸 Tucson, Arizona, United States

Orange Coast Women's Medical Group - Laguna Hills Office; 🇺🇸 Laguna Hills, California, United States

Physicians Research Options, LLC; 🇺🇸 Lakewood, Colorado, United States

M & O Clinical Research, LLC; 🇺🇸 Fort Lauderdale, Florida, United States

The Women's Health Group, P.C.; 🇺🇸 Thornton, Colorado, United States

Clinical Research Prime, LLLP; 🇺🇸 Idaho Falls, Idaho, United States

Physician Care Clinical Research; 🇺🇸 Sarasota, Florida, United States

John H Stroger Jr. Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

Women's Health Advantage; 🇺🇸 Fort Wayne, Indiana, United States

Office of Dr. Cindy Basinski, LLC; 🇺🇸 Newburgh, Indiana, United States

IU Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States

University of Kentucky Albert B. Chandler Hospital; 🇺🇸 Lexington, Kentucky, United States

Women's Health Care, PC; 🇺🇸 Newburgh, Indiana, United States

The Iowa Clinic, PC; 🇺🇸 West Des Moines, Iowa, United States

Mid-Atlantic Permanente Research Institute; 🇺🇸 Rockville, Maryland, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Horizon Research Group of Opelousas, LLC; 🇺🇸 Eunice, Louisiana, United States

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Women's Integrated Health Care, PC; 🇺🇸 Grand Blanc, Michigan, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Women's Health Alliance; 🇺🇸 Raleigh, North Carolina, United States

Unified Women's Clinical Research, LLC; 🇺🇸 Greensboro, North Carolina, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Wright State Physicians Health Center; 🇺🇸 Dayton, Ohio, United States

HWC Women's Research Center; 🇺🇸 Englewood, Ohio, United States

AC Clinical Research; 🇺🇸 Tiffin, Ohio, United States

HillTop Obstetrics & Gynecology; 🇺🇸 Franklin, Ohio, United States

Amy Brenner, MD & Associates, LLC; 🇺🇸 Mason, Ohio, United States

St. Luke's Hospital - Allentown Campus; 🇺🇸 Allentown, Pennsylvania, United States

Reading Hospital; 🇺🇸 West Reading, Pennsylvania, United States

Women's Health Care Group of PA; 🇺🇸 Pottstown, Pennsylvania, United States

Women & Infants Hospital (OGCC); 🇺🇸 Providence, Rhode Island, 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

OB-GYN Centre of Excellence; 🇺🇸 Chattanooga, Tennessee, United States

Tanner Clinic; 🇺🇸 Layton, Utah, United States

Tidewater Clinical Research, Inc.; 🇺🇸 Virginia Beach, Virginia, United States

Women's Healthcare Associates, LLC - Tualatin; 🇺🇸 Pleasant Grove, Utah, United States

Unified Women's Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Palmetto Clinical Research (PCR); 🇺🇸 Charleston, South Carolina, United States