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Adiana Post-Approval Clinical Study (APACS)

This study has been terminated.
(Hologic made business decision to no longer sell or manufacture Adiana device.)
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT01177670
First received: August 5, 2010
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

The Adiana Post-Approval Clinical Study (APACS) has been designed to compile information on the efficacy and safety of the Adiana Permanent Contraception System in the post market setting. Specifically, data will be collected that is relevant to the evaluation of the safety and efficacy of the Adiana System for women who desire permanent birth control by occlusion of the fallopian tubes. This study is an observational study that is not intended to test specific hypotheses.


Condition
Women Contraception

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adiana Post-Approval Clinical Study

Resource links provided by NLM:


Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:
  • Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception. [ Time Frame: At one and two years ] [ Designated as safety issue: No ]
    The primary efficacy endpoints are the one and two year pregnancy rates among women who have hysterosalpingogram (HSG)-proven bilateral occlusion and are informed that they may rely on the Adiana System for contraception.


Secondary Outcome Measures:
  • Safety Endpoints [ Time Frame: At one and two years ] [ Designated as safety issue: Yes ]
    The Adiana System will be evaluated for safety on the basis of the occurrence of adverse events which are related to the study device, unanticipated or serious.


Enrollment: 169
Study Start Date: August 2010
Study Completion Date: April 2012
Detailed Description:

Adiana Post-Approval Clinical Study is a prospective, single armed, multi-center, observational study that is designed to provide additional efficacy and safety data regarding the FDA-approved Adiana Permanent Contraception System. This study will be conducted at 8-10 clinical sites and enroll 1000 subjects. Enrolled subjects will have baseline data collected at the time of their Adiana procedure and will then be followed for a period of 2 years with visits occurring at 3 months following the Adiana procedure, 6 months following Adiana procedure (as applicable), 12 and 24 months post relying date.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women, 18 - 45 years old, at risk for pregnancy, that are seeking permanent contraception using the Adiana Permanent Contraception System.

Criteria

Inclusion Criteria:

  • Subjects who are seeking permanent sterilization
  • Women 18-45 years old
  • Subjects who are at risk of becoming pregnant
  • Subjects willing to use alternative contraception for at least three (3) months following device placement and bilateral tubal occlusion is confirmed by HSG
  • Subjects who are able to provide informed consent

Exclusion Criteria:

  • Subjects who are uncertain about their desire to end fertility
  • Clinical evidence of an active pelvic infection or history of a recent pelvic infection
  • Has intra-uterine pathology which would prevent access to either tubal ostium or the intramural portion of either fallopian tube (i.e., large submucous fibroids, uterine adhesions, apparent uni or bilateral proximal tubal occlusion, suspected unicornuate uterus, etc.)
  • Is pregnant (as evidenced by pregnancy test result) or suspects pregnancy
  • Is currently less than three (3) months since her last pregnancy
  • Has previously undergone a tubal ligation
  • Is currently taking immunosuppressive medication (e.g., steroids)
  • Has a known allergy to contrast media
  • Has external pacemaker or internal cardioverter defibrillator
  • Subject is unable to follow the protocol and return for follow up visits
  • In the opinion of the investigator, the subject has a medical condition that precludes safe participation in the study
  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: NCT01177670

Locations
United States, California
Sutter Medical Group
Elk Grove, California, United States, 95758
United States, Illinois
WomenCare, P.C.
Arlington Heights, Illinois, United States, 60004
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65203
United States, North Carolina
Valaoras & Lewis Obstetrics and Gynecology
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Complete Healthcare for Women
Columbus, Ohio, United States, 43231
United States, Oregon
The Women's Center of Central Oregon
Redmond, Oregon, United States, 97756
Salem Women's Clinic
Salem, Oregon, United States, 97302
United States, Pennsylvania
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Virginia
Ob/Gyn Associates of Danville
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Hologic, Inc.
Investigators
Study Director: Edward Evantash, MD Hologic, Inc.
  More Information

No publications provided

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT01177670     History of Changes
Other Study ID Numbers: S0210001
Study First Received: August 5, 2010
Results First Received: September 18, 2012
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hologic, Inc.:
Adiana Permanent Contraception System
women seeking permanent sterilization.

ClinicalTrials.gov processed this record on November 27, 2014