Essure (Model ESS310) Placement Rate Study

Bayer

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Device: ESS310 (BAY1454032)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02064413

17069

Details and patient eligibility

About

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.

Enrollment

134 patients

Sex

Female

Ages

21 to 44 years old

Volunteers

Accepts Healthy Volunteers

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)