Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Contraception Procedure: Blood draw Device: ESSURE (BAY1454032) Procedure: Laparoscopic tubal sterilization Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 990 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tubal Ligation

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Patient reported outcomes for health status [ Time Frame: Up to 60 months ]
    Medical Outcomes Study Short Form-36

  6. 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´.

  7. 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´.

  8. 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).

  9. Patient reported outcomes for bleeding by intermenstrual bleeding questions [ Time Frame: Up to 60 months ]
    Two questions used to characterize intermenstrual bleeding.

  10. Patient reported outcomes for centralized pain [ Time Frame: At baseline ]
    Assessed with the Fibromyalgia Survey Questionnaire

  11. 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.

  12. 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.

  13. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127722


Locations
Show Show 57 study locations
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03127722    
Other Study ID Numbers: 18894
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

Layout table for additional information
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