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Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

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: NCT01948882
Recruitment Status : Active, not recruiting
First Posted : September 24, 2013
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.

Condition or disease Intervention/treatment Phase
Contraception Device: ESS505 (BAY1454033) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 660 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model ESS505) Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
Actual Study Start Date : September 30, 2013
Actual Primary Completion Date : September 16, 2015
Estimated Study Completion Date : October 16, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ESS505
All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.
 Device: ESS505 (BAY1454033)


Outcome Measures
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Primary Outcome Measures :
  1. Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception [ Time Frame: 1 year ]
    Evaluated after 6000 women-months of reliance have been accumulated

  2. Reliance rate, defined as number of subjects told to rely on ESS505 after the Essure confirmation test divided by the number of subjects who had insert placement attempted [ Time Frame: 3 months ]
    Evaluated after 3000 women-months of reliance have been accumulated (expected at the same time most subjects with implants have completed their 3 month follow-up visit)


Secondary Outcome Measures :
  1. Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception [ Time Frame: 10 years ]
  2. Safety of the ESS505 placement procedure defined as number of subjects who experience an AE assessed as related to the ESS505 placement procedure divided by the number of subjects in who at least one ESS505 was introduced into the fallopian tube [ Time Frame: On day of placement procedure ]
  3. Safety of subsequent wearing of the insert defined as number of subjects who experience an AE assessed as related to wearing of ESS505 divided by the number of subjects in whom the presence of an AE could be assessed [ Time Frame: Up to 10 years ]

Eligibility Criteria
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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:

  • Female, 21 to 44 years of age, inclusive
  • Body weight within range of 90-300 lbs (40 - 136 kg)
  • Sexually active (minimum of 4 coital acts per cycle)
  • Willing to accept the risk of pregnancy while relying solely on the inserts for contraception
  • Medical history indicates bilateral viable and patent fallopian tubes
  • Agrees to fulfill local requirements for counseling and consent to contraception and sterilization, including any required waiting periods

Exclusion Criteria:

  • Post-menopausal woman
  • Suspected or confirmed pregnancy
  • Post-partum or pregnancy termination ≤6 weeks of scheduled insert placement
  • Past fallopian tube sterilization procedure and/or total or partial salpingectomies
  • Diagnosis of any of the following: tubal, endometrial, or myometrial pathology (which may prevent fallopian tube ostia access), proximal tubal occlusion in either fallopian tube, unicornuate uterus, active or recent upper or lower pelvic infection, gynecologic malignancy
  • Currently taking corticosteroids
  • Known allergy to all contrast media available for use in hysterosalpingogram
  • Scheduled to undergo concomitant intrauterine procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure)
  • 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
Contacts and Locations
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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): NCT01948882


Locations
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United States, Colorado
Aurora, Colorado, United States, 80012
Aurora, Colorado, United States, 80045
United States, Florida
Boynton Beach, Florida, United States, 33472-2952
United States, Illinois
Arlington Heights, Illinois, United States, 60004
United States, Indiana
Fort Wayne, Indiana, United States, 46825
Newburgh, Indiana, United States, 47630
United States, Michigan
Saginaw, Michigan, United States, 48604
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
Bronx, New York, United States, 10467
New York, New York, United States, 10019
United States, North Carolina
Asheville, North Carolina, United States, 28801
United States, Ohio
Cincinnati, Ohio, United States, 45231
United States, Texas
Dallas, Texas, United States, 75208
Houston, Texas, United States, 77074
Irving, Texas, United States, 75062
United States, Virginia
Norfolk, Virginia, United States, 23507
United States, Washington
Spokane, Washington, United States, 99204
Canada, Ontario
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4S 6X3
Netherlands
Zwolle, Netherlands, 8025 AB
Spain
L'Hospitalet de llobregat, Barcelona, Spain, 08906
Córdoba, Spain, 14004
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01948882    
Other Study ID Numbers: 16973
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Keywords provided by Bayer:
Birth control