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

ID: NCT03127722
Status: Recruiting
Phase: N/A
Start Date: May 03, 2017
First Submitted: March 05, 2017
Last Updated: February 23, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: United States
Conditions: Contraception
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Study Description

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

Condition or disease Intervention/treatment Phase

Contraception

Procedure: Blood draw
Other Names
Device: ESSURE (BAY1454032)
Other Names
Procedure: Laparoscopic tubal sterilization
Other Names
N/A

Tracking Information

First Submitted DateMarch 05, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateMay 03, 2017
Anticipated Completion DateMay 29, 2023
Actual Primary Completion DateMay 29, 2023
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Fibromyalgia Survey Questionnaire [Time Frame: Up to 36 months]

    Measure of a centralized pain state

  • Patient reported outcomes for bleeding [Time Frame: Up to 36 months]

    Aberdeen Menorrhagia Severity Scale and two intermenstrual bleeding questions used to characterize bleeding

  • 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?"

  • 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 health status [Time Frame: Up to 36 months]

    Medical Outcomes Study Short Form-36

  • 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.

  • 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.

  • 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.

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization
Official TitleAn 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

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
2800
Allocation
Non-Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Other
Conditions
Contraception
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
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 and 12 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization

Other Names
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

Other Names
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

Other Names
Study Groups/Cohorts
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.

Laparoscopic tubal sterilization
Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care

Study Arms
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 and 12 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization

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.
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 : 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

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 and 12 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization

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
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.
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
Procedure : Laparoscopic tubal sterilization
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

Recruitment Information

Recruitment Status:Recruiting
Enrollment2800
Completion DateMay 29, 2023
Eligibility Criteria: Inclusion Criteria:
- Subjects who are 21 to 45 years of age
- Subjects who are between 90 and 300 pounds
- 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
GenderFemale
Age21 Years to 45 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03127722
Other Study ID Numbers
18894
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer