check_circleStudy Completed

Contraception

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

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