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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03127722
• Other study ID #: 18894
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 990
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

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.

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.

Locations

Country	Name	City	State
United States	St. Luke's Hospital - Allentown Campus	Allentown	Pennsylvania
United States	Tufts Medical Center	Boston	Massachusetts
United States	New Horizons Women's Care	Chandler	Arizona
United States	Palmetto Clinical Research (PCR)	Charleston	South Carolina
United States	OB-GYN Centre of Excellence	Chattanooga	Tennessee
United States	John H Stroger Jr. Hospital of Cook County	Chicago	Illinois
United States	Seven Hills Women's Health Centers	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Columbus OB-GYN/Radiant Research	Columbus	Ohio
United States	Complete Healthcare for Women, Inc.	Columbus	Ohio
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	Horizon Research Group of Opelousas, LLC	Eunice	Louisiana
United States	M & O Clinical Research, LLC	Fort Lauderdale	Florida
United States	Women's Health Advantage	Fort Wayne	Indiana
United States	HillTop Obstetrics & Gynecology	Franklin	Ohio
United States	Women's Integrated Health Care, PC	Grand Blanc	Michigan
United States	Unified Women's Clinical Research, LLC	Greensboro	North Carolina
United States	Ben Taub General Hospital	Houston	Texas
United States	Southeast Texas Family Planning and Cancer Screening	Houston	Texas
United States	The Woman's Hospital of Texas	Houston	Texas
United States	United Clinical Research	Huntington Beach	California
United States	Clinical Research Prime, LLLP	Idaho Falls	Idaho
United States	IU Health University Hospital	Indianapolis	Indiana
United States	Brown Stone Clinical Trials, LLC	Irving	Texas
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Orange Coast Women's Medical Group - Laguna Hills Office	Laguna Hills	California
United States	Altus Research	Lake Worth	Florida
United States	Physicians Research Options, LLC	Lakewood	Colorado
United States	Tanner Clinic	Layton	Utah
United States	University of Kentucky Albert B. Chandler Hospital	Lexington	Kentucky
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Amy Brenner, MD & Associates, LLC	Mason	Ohio
United States	Universal Axon Clinical Research	Miami	Florida
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	Office of Dr. Cindy Basinski, LLC	Newburgh	Indiana
United States	Women's Health Care, PC	Newburgh	Indiana
United States	Oklahoma University	Oklahoma City	Oklahoma
United States	Precision Trials, AZ, LLC	Phoenix	Arizona
United States	Women's Healthcare Associates, LLC - Tualatin	Pleasant Grove	Utah
United States	Oregon Health and Science University	Portland	Oregon
United States	Women's Health Care Group of PA	Pottstown	Pennsylvania
United States	Women & Infants Hospital (OGCC)	Providence	Rhode Island
United States	Women's Health Alliance	Raleigh	North Carolina
United States	Mid-Atlantic Permanente Research Institute	Rockville	Maryland
United States	Physician Care Clinical Research	Sarasota	Florida
United States	The Women's Health Group, P.C.	Thornton	Colorado
United States	AC Clinical Research	Tiffin	Ohio
United States	Eclipse Clinical Research	Tucson	Arizona
United States	Visions Clinical Research - Tucson	Tucson	Arizona
United States	Tidewater Clinical Research, Inc.	Virginia Beach	Virginia
United States	The Iowa Clinic, PC	West Des Moines	Iowa
United States	Reading Hospital	West Reading	Pennsylvania
United States	Unified Women's Clinical Research	Winston-Salem	North Carolina
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Patient reported outcomes for health status	Medical Outcomes Study Short Form-36	Up to 60 months
Primary	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
Primary	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
Primary	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
Primary	Patient reported outcomes for bleeding by intermenstrual bleeding questions	Two questions used to characterize intermenstrual bleeding.	Up to 60 months
Primary	Patient reported outcomes for centralized pain	Assessed with the Fibromyalgia Survey Questionnaire	At baseline
Primary	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
Primary	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
Primary	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

External Links

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