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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03127722
Recruitment Status : Active, not recruiting
First Posted : April 25, 2017
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE March 5, 2017
First Posted Date  ICMJE April 25, 2017
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE May 3, 2017
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2019)
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 60 months ]
    Medical Outcomes Study Short Form-36
  • Patient reported outcomes for pain intensity [ Time Frame: 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 pain interference [ Time Frame: 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 bleeding by AMSS [ Time Frame: 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 [ Time Frame: Up to 60 months ]
    Two questions used to characterize intermenstrual bleeding.
  • Patient reported outcomes for centralized pain [ Time Frame: At baseline ]
    Assessed with the Fibromyalgia Survey Questionnaire
  • Patient reported outcomes on adverse events from device reports [ Time Frame: 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.
  • Patient reported outcomes on media sources for their medical decisioning [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • 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 proportion of AEs of chronic lower abdominal and/or pelvic pain [ Time Frame: Up to 36 months ]
    All AEs will be assessed and documented by the investigator according to seriousness, intensity, action taken, treatments, outcome and causal relationship.
  • 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 [ Time Frame: Up to 36 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 [ Time Frame: Up to 36 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 [ Time Frame: Up to 36 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 [ Time Frame: Up to 36 months ]
    Medical Outcomes Study Short Form-36
  • Rates of AEs in subjects undergoing Essure placement and laparoscopic tubal sterilization [ Time Frame: Up to 36 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 [ Time Frame: Up to 36 months ]
    Patient-Reported Outcomes Measurement Information System Scale V1.0, Pain Intensity 3a and Pain Interference 8a Participant Format, if the response is "Yes" to the question "Did you experience pain in your pelvic area or in your lower abdomen during the past week?"
  • Patient reported outcomes for bleeding [ Time Frame: Up to 36 months ]
    Aberdeen Menorrhagia Severity Scale and two intermenstrual bleeding questions used to characterize bleeding
  • Fibromyalgia Survey Questionnaire [ Time Frame: Up to 36 months ]
    Measure of a centralized pain state
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Contraception
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Blood draw
    • Device: ESSURE (BAY1454032)
  • 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
    Interventions:
    • Procedure: Blood draw
    • Procedure: Laparoscopic tubal sterilization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 30, 2020)
990
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2017)
2800
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03127722
Other Study ID Numbers  ICMJE 18894
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP