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Essure (Model ESS310) Placement Rate Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02064413
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Contraception Device: ESS310 (BAY1454032) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-Center, United States Clinical Study to Evaluate Placement Success of the ESS310 Essure® System
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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)



Primary Outcome Measures :
  1. Rate of successful bilateral placement of the ESS310 insert at first attempt in subjects who undergo attempted ESS310 placement [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Day 1 ]
  2. Evaluation of investigator questionnaire regarding ESS310 design and usability [ Time Frame: Day 1 ]
    Potential aspects of the ESS310 design and usability that may impact bilateral placement rate at first attempt

  3. Evaluation of investigator questionnaire regarding potential factors predictive of failure to achieve bilateral placement of the ESS310 insert at first attempt [ Time Frame: Day 1 ]
  4. Hysteroscopy time to perform the procedure [ Time Frame: Day 1 ]
  5. Number of participants with Adverse device effects (ADE) as a measure of safety and tolerability [ Time Frame: 1 week ]
  6. Number of participants with Adverse procedure-related events as a measure of safety and tolerability [ Time Frame: Day 1, 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064413


Locations
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United States, Arizona
Glendale, Arizona, United States, 85304
Phoenix, Arizona, United States, 85015
United States, Colorado
Colorado Springs, Colorado, United States, 80923
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Indiana
Fort Wayne, Indiana, United States, 46825
Newburgh, Indiana, United States, 47630
United States, Michigan
Grand Blanc, Michigan, United States, 48439
Saginaw, Michigan, United States, 48604
Southfield, Michigan, United States, 48034
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Dayton, Ohio, United States, 45409-2793
United States, Tennessee
Nashville, Tennessee, United States, 37205
Nashville, Tennessee, United States, 37232
United States, Texas
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77074
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02064413     History of Changes
Other Study ID Numbers: 17069
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: November 2015

Keywords provided by Bayer:
Birth control