A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System

Bayer4 sites in 1 country134 target enrollmentMarch 17, 2014

ConditionsContraception

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Contraception
Sponsor: Bayer
Enrollment: 134
Locations: 4
Primary Endpoint: Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 17, 2014

End Date

November 26, 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement

Time Frame: Day 1

Secondary Outcomes

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(Day 1)
Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability(1 week)
Evaluation of investigator questionnaire regarding ESS310 design and usability(Day 1)
Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt(Day 1)
Hysteroscopy time to perform the procedure(Day 1)
Number of participants with Adverse procedure-related events as a measure of safety and tolerability(Day 1, 1 week)