check_circleStudy Completed

Contraception

Bayer Identifier:

18894

ClinicalTrials.gov Identifier:

NCT03127722

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to assess outcomes in women undergoing either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization

Trial purpose

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 Participants Requirements

Sex

Female

Age

21 - N/A
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
990
Trial Dates
May 2017 - December 2024
Phase
N/A
Could I Receive a placebo
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Active, not recruiting
New Horizons Women's CareChandler, 85224, United States
Active, not recruiting
Visions Clinical Research - TucsonTucson, 85712, United States
Active, not recruiting
Brown Stone Clinical Trials, LLCIrving, 75061, United States
Completed
Southeast Texas Family Planning and Cancer ScreeningHouston, 77074, United States
Withdrawn
Virginia Women's CenterRichmond, 23233, United States
Active, not recruiting
Office of Dr. Cindy Basinski, LLCNewburgh, 47630, United States
Active, not recruiting
Brown Stone Clinical Trials, LLCIrving, 75061, United States
Active, not recruiting
Columbus OB-GYN/Radiant ResearchColumbus, 43213, United States
Active, not recruiting
Complete Healthcare for Women, Inc.Columbus, 43231, United States
Active, not recruiting
Women's Integrated Health Care, PCGrand Blanc, 48439, United States
Active, not recruiting
Women's Health AdvantageFort Wayne, 46825, United States
Active, not recruiting
University of Tennessee Medical CenterKnoxville, 37920, United States
Active, not recruiting
Horizon Research Group of Opelousas, LLCEunice, 70535, United States
Active, not recruiting
OB-GYN Centre of ExcellenceChattanooga, 37404, United States
Active, not recruiting
Tufts Medical CenterBoston, 02111, United States
Active, not recruiting
Women's Health AllianceRaleigh, 27607, United States
Active, not recruiting
Amy Brenner, MD & Associates, LLCMason, 45040, United States
Active, not recruiting
John H Stroger Jr. Hospital of Cook CountyChicago, 60612, United States
Active, not recruiting
Women's Health Care Group of PAPottstown, 19464, United States
Active, not recruiting
MetroHealth Medical CenterCleveland, 44109-1998, United States
Active, not recruiting
Women's Health Care, PCNewburgh, 47630, United States
Completed
Brown Stone Clinical Trials, LLCIrving, 75061, United States
Completed
The Woman's Hospital of TexasHouston, 77054, United States
Active, not recruiting
Wake Forest Baptist HealthWinston-Salem, 27157-1009, United States
Active, not recruiting
Jersey Shore University Medical CenterNeptune, 07753, United States
Completed
Oklahoma UniversityOklahoma City, 73104, United States
Completed
University of Kentucky Albert B. Chandler HospitalLexington, 40536-0001, United States
Active, not recruiting
Wright State Physicians Health CenterDayton, 45405-4534, United States
Active, not recruiting
Columbia University Medical CenterNew York, 10032, United States
Completed
IU Health University HospitalIndianapolis, 46202, United States
Active, not recruiting
AC Clinical ResearchTiffin, 44883-2820, United States
Active, not recruiting
Reading HospitalWest Reading, 19611, United States
Active, not recruiting
United Clinical ResearchHuntington Beach, 90255, United States
Active, not recruiting
The Women's Health Group, P.C.Thornton, 80229-4388, United States
Completed
St. Luke's Hospital - Allentown CampusAllentown, 18104-9701, United States
Active, not recruiting
Precision Trials, AZ, LLCPhoenix, 85032, United States
Completed
Ben Taub General HospitalHouston, 77030, United States
Active, not recruiting
HWC Women’s Research CenterEnglewood, 45322, United States
Active, not recruiting
HillTop Obstetrics & GynecologyFranklin, 45005-2593, United States
Active, not recruiting
Tanner ClinicLayton, 84041-8803, United States
Active, not recruiting
Brown Stone Clinical Trials, LLCIrving, 75061, United States
Withdrawn
Hutzel Women’s HospitalDetroit, 48201, United States
Completed
Physician Care Clinical ResearchSarasota, 34239, United States
Active, not recruiting
Tidewater Clinical Research, Inc.Virginia Beach, 23456, United States
Withdrawn
Sparrow Clinical Research InstituteLansing, 48912, United States
Active, not recruiting
Women & Infants Hospital (OGCC)Providence, 02905, United States
Active, not recruiting
Seven Hills Women's Health CentersCincinnati, 45242, United States
Withdrawn
Emerald Coast Obstetrics & GynecologyPanama City, 32405-4501, United States
Active, not recruiting
Palmetto Clinical Research (PCR)Charleston, 29406-9126, United States
Active, not recruiting
Unified Women's Clinical ResearchWinston Salem, 27103-1749, United States
Active, not recruiting
Eclipse Clinical ResearchTuscon, 85745-2696, United States
Active, not recruiting
Ohio State UniversityColumbus, 43210, United States
Active, not recruiting
Clinical Research Prime, LLLPIdaho Falls, 83402-3344, United States
Active, not recruiting
Unified Women's Clinical Research, LLCGreensboro, 27401-1207, United States
Active, not recruiting
Mid-Atlantic Permanente Research InstituteRockville, 20852, United States
Withdrawn
Axcess Medical Research, LLCLoxahatchee, 33470, United States
Active, not recruiting
Baptist Health Center for Clinical ResearchLittle Rock, 72205-6325, United States
Active, not recruiting
Women's Healthcare Associates, LLC - TualatinPleasant Grove, 84062-4097, United States
Active, not recruiting
Orange Coast Women's Medical Group - Laguna Hills OfficeLaguna Hills, 92653, United States
Withdrawn
Washington University School of MedicineSt. Louis, 63110, United States
Active, not recruiting
Physicians Research Options, LLCLakewood, 80228, United States
Completed
Altus ResearchLake Worth, 33461, United States
Active, not recruiting
M & O Clinical Research, LLCFt. Lauderdale, 33316, United States
Active, not recruiting
Universal Axon Clinical ResearchMiami, 33166, United States
Active, not recruiting
Oregon Health and Science UniversityPortland, 97239, United States
Active, not recruiting
The Iowa Clinic, PCWest Des Moines, 50266-8289, United States

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Patient reported outcomes for health status
    Medical Outcomes Study Short Form-36
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    Yes
  • 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´.
    date_rangeTime Frame:
    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´.
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    Up to 60 months
  • Patient reported outcomes for bleeding by intermenstrual bleeding questions
    Two questions used to characterize intermenstrual bleeding.
    date_rangeTime Frame:
    Up to 60 months
  • Patient reported outcomes for centralized pain
    Assessed with the Fibromyalgia Survey Questionnaire
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Up to 60 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Procedure/Surgery
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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