Trial Condition(s):

Contraception

Essure (Model ESS310) Placement Rate Study

Bayer Identifier:

17069

ClinicalTrials.gov Identifier:

NCT02064413

EudraCT Number:

Not Available

Study Completed

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.

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)

Trial Summary

Enrollment Goal
134
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
ESS310 (BAY1454032)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Tennessee Women's Care, PC

Nashville, United States, 37205

Status
Terminated
 
Locations

Vanderbilt University Medical Center

Nashville, United States, 37232

Status
Terminated
 
Locations

Mayo Clinic - Rochester

Rochester, United States, 55905

Status
Terminated
 
Locations

Investigative Site

Augusta, United States, 30909

Status
Completed
 
Locations

Investigative Site

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Investigative Site

Colorado Springs, United States, 80923

Status
Completed
 
Locations

Investigative Site

Glendale, United States, 85304

Status
Completed
 
Locations

Investigative Site

Saginaw, United States, 48604

Status
Completed
 
Locations

Investigative Site

Newburgh, United States, 47630

Status
Completed
 
Locations

Investigative Site

Grand Blanc, United States, 48439

Status
Completed
 
Locations

Investigative Site

Phoenix, United States, 85015

Status
Completed
 
Locations

Wayne State University Physicians Group

Southfield, United States, 48034

Status
Completed
 
Locations

Investigative Site

Fort Worth, United States, 76104

Status
Completed
 
Locations

Investigative Site

Dayton, United States, 45409-2793

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77074

Status
Completed
 
Locations

Investigative Site

Fort Wayne, United States, 46825

Status
Completed
 

Trial Design