check_circleStudy Completed

Contraception

Bayer Identifier:

17069

ClinicalTrials.gov Identifier:

NCT02064413

EudraCT Number:

Not Available

EU CT Number:

Not Available
Essure (Model ESS310) Placement Rate Study

Trial purpose

To evaluate the safety and successful placement rate of Essure Model ESS310 device and any factors that may influence the successful placement rate of this device.

Key Participants Requirements

Sex

Female

Age

21 - 44 Years
  • - Females aged range 21 to 44 years
    - Subjects seeking permanent contraception
    - Subjects with body weight within range of 90-300 pounds (40 – 136 kilograms)
    - Subjects for whom medical history indicates bilateral viable and patent fallopian tubes
    - Subjects are able and willing to comply with the protocol required follow-up visits
    - Subjects have fulfilled local requirements for counseling and consent to contraception and sterilization, including any required waiting periods
    - Subjects provide written informed consent prior to enrolment
    - Subjects who have sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience implant and subsequent wearing of the device
    - Subjects who agree that anonymized personal data will be made available to study Sponsor and requisite regional and international regulatory bodies
  • - Subjects suspected of being or confirmed pregnant
    - Subjects post-partum or undergone pregnancy termination ≤6 weeks of scheduled insert placement
    - Subjects who have known proximal tubal occlusion in either fallopian tube
    - Subjects who have undergone fallopian tube sterilization procedure
    - Subjects who have had total or partial salpingectomies
    - Subjects diagnosed with tubal, endometrial, or myometrial pathology which may prevent fallopian tube ostia access
    - Subjects diagnosed with unicornuate uterus
    - Subjects diagnosed with active or currently being treated upper or lower pelvic infection
    - Subjects with gynecologic malignancy
    - Subjects who are currently taking corticosteroids
    - Subjects with a known allergy to all contrast media available for use in HSG (Hysterosalpingogram)
    - Subjects scheduled to undergo concomitant intrauterine procedures at the time of insert placement (e.g., endometrial ablation, fibroid resection by hysteroscopy, endometrial polypectomy). Intrauterine device removal is not considered a concomitant procedure.
    - Subjects with any general health condition or systemic disease that may represent, in the opinion of the physician, a potential increased risk associated with device use or pregnancy
    - Subjects with a close affiliation with the investigational site, e.g. closely related or affiliated with the investigator (such as dependent, employee or student of the investigational site, or sponsor’s staff)

Trial summary

Enrollment Goal
134
Trial Dates
March 2014 - November 2014
Phase
Phase 3
Could I Receive a placebo
No
Products
ESS310 (BAY1454032)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Terminated
Tennessee Women's Care, PCNashville, 37205, United States
Terminated
Vanderbilt University Medical CenterNashville, 37232, United States
Terminated
Mayo Clinic - RochesterRochester, 55905, United States
Completed
Augusta, 30909, United States
Completed
Winston-Salem, 27103, United States
Completed
Colorado Springs, 80923, United States
Completed
Glendale, 85304, United States
Completed
Saginaw, 48604, United States
Completed
Newburgh, 47630, United States
Completed
Grand Blanc, 48439, United States
Completed
Phoenix, 85015, United States
Completed
Wayne State University Physicians GroupSouthfield, 48034, United States
Completed
Fort Worth, 76104, United States
Completed
Dayton, 45409-2793, United States
Completed
Houston, 77074, United States
Completed
Fort Wayne, 46825, United States

Primary Outcome

  • Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Successful bilateral placement rate of the ESS310 insert at first attempt in all subjects who undergo hysteroscopy with the intent of having bilateral ESS310 placement
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of investigator questionnaire regarding ESS310 design and usability
    Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No
  • Hysteroscopy time to perform the procedure
    date_rangeTime Frame:
    Day 1
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability
    date_rangeTime Frame:
    1 week
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with Adverse procedure-related events as a measure of safety and tolerability
    date_rangeTime Frame:
    Day 1, 1 week
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Prevention
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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