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.
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.
Study Type
OBSERVATIONAL
Enrollment
169
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
Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.
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.
Time frame: At one and two years
Safety Endpoints
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.
Time frame: At one and two years
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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