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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01948882
First received: September 19, 2013
Last updated: July 7, 2015
Last verified: July 2015
  Purpose

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 Intervention
Contraception
Device: ESS505 (BAY1454033)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of confirmed pregnancies at 1 year among subjects told to rely on ESS505 for contraception [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Evaluated after 6000 women-months of reliance have been accumulated

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Number of confirmed pregnancies at 10 years among subjects told to rely on ESS505 for contraception [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 612
Study Start Date: September 2013
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESS505
All subjects that sign the informed consent and meet the eligibility criteria will be scheduled for an implant procedure.
Device: ESS505 (BAY1454033)

  Eligibility

Ages Eligible for Study:   21 Years to 44 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948882

  Show 23 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01948882     History of Changes
Other Study ID Numbers: 16973
Study First Received: September 19, 2013
Last Updated: July 7, 2015
Health Authority: Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Dutch Health Care Inspectorate
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Bayer:
Birth control

ClinicalTrials.gov processed this record on August 27, 2015