Essure (Model ESS310) Placement Rate Study

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: ESS310 (BAY1454032)

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85304
    • Phoenix, Arizona, United States, 85015
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
  • Georgia
    • Augusta, Georgia, United States, 30909
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
    • Newburgh, Indiana, United States, 47630
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
    • Saginaw, Michigan, United States, 48604
    • Southfield, Michigan, United States, 48034
      • Wayne State University Physicians Group
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Dayton, Ohio, United States, 45409-2793
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37205
      • Tennessee Women's Care, PC
  • Texas
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77074

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESS310; All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.	Device: ESS310 (BAY1454032)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt	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
Number of participants with Adverse procedure-related events as a measure of safety and tolerability		Day 1, 1 week

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2014
• Primary Completion (Actual): October 2, 2014
• Study Completion (Actual): November 26, 2014

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Birth control
• Other Study ID Numbers: 17069