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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception
• Intervention / Treatment: Procedure: Blood draw; Device: ESSURE (BAY1454032); Procedure: Laparoscopic tubal sterilization

• Study Type: Interventional
• Enrollment (Actual): 990
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • New Horizons Women's Care
    • Phoenix, Arizona, United States, 85032
      • Precision Trials, AZ, LLC
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research - Tucson
    • Tucson, Arizona, United States, 85745-2696
      • Eclipse Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-6325
      • Baptist Health Center for Clinical Research
  • California
    • Huntington Beach, California, United States, 90255
      • United Clinical Research
    • Laguna Hills, California, United States, 92653
      • Orange Coast Women's Medical Group - Laguna Hills Office
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Physicians Research Options, LLC
    • Thornton, Colorado, United States, 80229-4388
      • The Women's Health Group, P.C.
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • M & O Clinical Research, LLC
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Miami, Florida, United States, 33166
      • Universal Axon Clinical Research
    • Sarasota, Florida, United States, 34239
      • Physician Care Clinical Research
  • Idaho
    • Idaho Falls, Idaho, United States, 83402-3344
      • Clinical Research Prime, LLLP
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H Stroger Jr. Hospital of Cook County
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Women's Health Advantage
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital
    • Newburgh, Indiana, United States, 47630
      • Office of Dr. Cindy Basinski, LLC
    • Newburgh, Indiana, United States, 47630
      • Women's Health Care, PC
  • Iowa
    • West Des Moines, Iowa, United States, 50266-8289
      • The Iowa Clinic, PC
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0001
      • University of Kentucky Albert B. Chandler Hospital
  • Louisiana
    • Eunice, Louisiana, United States, 70535
      • Horizon Research Group of Opelousas, LLC
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Mid-Atlantic Permanente Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Women's Integrated Health Care, PC
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Greensboro, North Carolina, United States, 27401-1207
      • Unified Women's Clinical Research, LLC
    • Raleigh, North Carolina, United States, 27607
      • Women's Health Alliance
    • Winston-Salem, North Carolina, United States, 27103-1749
      • Unified Women's Clinical Research
    • Winston-Salem, North Carolina, United States, 27157-1009
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Seven Hills Women's Health Centers
    • Cleveland, Ohio, United States, 44109-1998
      • MetroHealth Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Columbus, Ohio, United States, 43213
      • Columbus OB-GYN/Radiant Research
    • Columbus, Ohio, United States, 43231
      • Complete Healthcare for Women, Inc.
    • Dayton, Ohio, United States, 45405-4534
      • Wright State Physicians Health Center
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center
    • Franklin, Ohio, United States, 45005-2593
      • HillTop Obstetrics & Gynecology
    • Mason, Ohio, United States, 45040
      • Amy Brenner, MD & Associates, LLC
    • Tiffin, Ohio, United States, 44883-2820
      • AC Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104-9701
      • St. Luke's Hospital - Allentown Campus
    • Pottstown, Pennsylvania, United States, 19464
      • Women's Health Care Group of PA
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital (OGCC)
  • South Carolina
    • Charleston, South Carolina, United States, 29406-9126
      • Palmetto Clinical Research (PCR)
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • OB-GYN Centre of Excellence
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
  • Texas
    • Houston, Texas, United States, 77054
      • The Woman's Hospital of Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital
    • Houston, Texas, United States, 77074
      • Southeast Texas Family Planning and Cancer Screening
    • Irving, Texas, United States, 75061
      • Brown Stone Clinical Trials, LLC
  • Utah
    • Layton, Utah, United States, 84041-8803
      • Tanner Clinic
    • Pleasant Grove, Utah, United States, 84062-4097
      • Women's Healthcare Associates, LLC - Tualatin
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
      • Tidewater Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Device: 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.
Active Comparator: Laparoscopic tubal sterilization; Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care	Procedure: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.	Up to 60 months
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	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.	Up to 60 months
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	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.	Up to 60 months
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	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.	Up to 60 months
Patient reported outcomes for health status	Medical Outcomes Study Short Form-36	Up to 60 months
Patient reported outcomes for pain intensity	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´.	Up to 60 months
Patient reported outcomes for pain interference	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´.	Up to 60 months
Patient reported outcomes for bleeding by AMSS	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).	Up to 60 months
Patient reported outcomes for bleeding by intermenstrual bleeding questions	Two questions used to characterize intermenstrual bleeding.	Up to 60 months
Patient reported outcomes for centralized pain	Assessed with the Fibromyalgia Survey Questionnaire	At baseline
Patient reported outcomes on adverse events from device reports	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.	Up to 60 months
Patient reported outcomes on media sources for their medical decisioning	Assessed by Social Media questionnaire to elicit information about sources of influence on medical decisions.	Up to 60 months
Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilization	All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.	Up to 60 months

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

Helpful Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 5, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No