Essure (Model ESS310) Placement Rate Study

Recruitment & Eligibility

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)

Study & Design

Arm && Interventions

Group	Intervention	Description
ESS310	ESS310 (BAY1454032)	All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.

Primary Outcome Measures

Name	Time	Method
Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement	Day 1

Secondary Outcome Measures

Name	Time	Method
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	Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt
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

Trial Locations

Locations (4)

Tennessee Women's Care, PC

🇺🇸

Nashville, Tennessee, United States

Wayne State University Physicians Group

🇺🇸

Southfield, Michigan, United States

Mayo Clinic - Rochester

🇺🇸

Rochester, Minnesota, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

Recruitment & Eligibility