Adiana Post-Approval Clinical Study (APACS)

Stopped early

Conditions studied: Women Contraception

In brief

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.

Key facts

Study ID

NCT01177670

Run by

Hologic, Inc.

People needed

169

Starts

2010-08-01

Expected to finish

2012-04-01

Last updated by the study team

2012-11-20

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sutter Medical Group — Elk Grove, California, United States
• WomenCare, P.C. — Arlington Heights, Illinois, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• Valaoras & Lewis Obstetrics and Gynecology — Winston-Salem, North Carolina, United States
• Complete Healthcare for Women — Columbus, Ohio, United States
• The Women's Center of Central Oregon — Redmond, Oregon, United States
• Salem Women's Clinic — Salem, Oregon, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• Ob/Gyn Associates of Danville — Danville, Virginia, United States

Full record on ClinicalTrials.gov

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