Essure (Model ESS310) Placement Rate Study

Contraception Clinical Trial

Official title:

A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064413
• Other study ID #: 17069
• Status: Completed
• Phase: Phase 3
• Start date: March 17, 2014
• Est. completion date: November 26, 2014

Study information

• Verified date: April 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: November 26, 2014
• Est. primary completion date: October 2, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 44 Years

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)

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• ESS310 (BAY1454032)

Locations

Country	Name	City	State
United States	Tennessee Women's Care, PC	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Wayne State University Physicians Group	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement		Day 1
Secondary	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
Secondary	Evaluation of investigator questionnaire regarding ESS310 design and usability	Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt	Day 1
Secondary	Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt		Day 1
Secondary	Hysteroscopy time to perform the procedure		Day 1
Secondary	Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability		1 week
Secondary	Number of participants with Adverse procedure-related events as a measure of safety and tolerability		Day 1, 1 week

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