Adiana Post-Approval Clinical Study (APACS)

Terminated

Brief Summary: 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.

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.	At one and two years	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

Name	Time	Method
Safety Endpoints	At one and two years	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.

Locations (9): Complete Healthcare for Women
🇺🇸
Columbus, Ohio, United States
WomenCare, P.C.
🇺🇸
Arlington Heights, Illinois, United States
Sutter Medical Group
🇺🇸
Elk Grove, California, United States
University of Missouri Health Care
🇺🇸
Columbia, Missouri, United States
Valaoras & Lewis Obstetrics and Gynecology
🇺🇸
Winston-Salem, North Carolina, 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