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

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.

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.

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.

Secondary Outcome Measures

Name	Time	Method

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

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

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

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