Clinical trial NCT02064413: Essure (Model ESS310) Placement Rate Study
Official title: A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Birth control
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 134
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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
* 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)

Primary outcomes:
measure: Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement
timeFrame: Day 1
Secondary outcomes:
measure: 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
timeFrame: Day 1
measure: Evaluation of investigator questionnaire regarding ESS310 design and usability
timeFrame: Day 1
measure: Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt
timeFrame: Day 1
measure: Hysteroscopy time to perform the procedure
timeFrame: Day 1
measure: Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability
timeFrame: 1 week
measure: Number of participants with Adverse procedure-related events as a measure of safety and tolerability
timeFrame: Day 1, 1 week
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Colorado Springs
country: United States
state: Colorado
city: Augusta
country: United States
state: Georgia
city: Fort Wayne
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Grand Blanc
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Southfield
country: United States
facility: Wayne State University Physicians Group
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Winston-Salem
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Nashville
country: United States
facility: Tennessee Women's Care, PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: