Essure (Model ESS310) Placement Rate Study

Completed · Phase 3

Conditions studied: Contraception

In brief

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 facts

Study ID

NCT02064413

Run by

Bayer

People needed

134

Starts

2014-03-17

Expected to finish

2014-11-26

Last updated by the study team

2021-04-08

Who can join

Age: 21 and older, up to 44. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Augusta, Georgia, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Newburgh, Indiana, United States
• Study site — Grand Blanc, Michigan, United States
• Study site — Saginaw, Michigan, United States
• Wayne State University Physicians Group — Southfield, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Dayton, Ohio, United States
• Tennessee Women's Care, PC — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Study site — Fort Worth, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.