Essure (Model ESS310) Placement Rate Study

NCT02064413 | Completed Phase 3

• 1 other identifier: 17069
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Contraception

Keywords

Birth control

Outcome Measures

Primary Outcomes (1)

• Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement

  Day 1

Secondary Outcomes (6)

• 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

• Evaluation of investigator questionnaire regarding ESS310 design and usability

  Day 1

• 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 device effects (ADE) as a measure of safety and tolerability

  1 week

Study Arms (1)

ESS310

EXPERIMENTAL

All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.

Device: ESS310 (BAY1454032)

Interventions

ESS310 (BAY1454032) DEVICE

ESS310

Eligibility Criteria

• Age: 21 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (16)

Unknown Facility

Glendale, Arizona, 85304, United States

Location

Unknown Facility

Phoenix, Arizona, 85015, United States

Location

Unknown Facility

Colorado Springs, Colorado, 80923, United States

Location

Unknown Facility

Augusta, Georgia, 30909, United States

Location

Unknown Facility

Fort Wayne, Indiana, 46825, United States

Location

Unknown Facility

Newburgh, Indiana, 47630, United States

Location

Unknown Facility

Grand Blanc, Michigan, 48439, United States

Location

Unknown Facility

Saginaw, Michigan, 48604, United States

Location

Wayne State University Physicians Group

Southfield, Michigan, 48034, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Dayton, Ohio, 45409-2793, United States

Location

Tennessee Women's Care, PC

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Fort Worth, Texas, 76104, United States

Location

Unknown Facility

Houston, Texas, 77074, United States

Location

Related Links

• Click here to find results for studies related to Bayer Healthcare products.

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 17, 2014
• Study Start: March 17, 2014
• Primary Completion: October 2, 2014
• Study Completion: November 26, 2014
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (16)