Adiana Post-Approval Clinical Study (APACS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adiana Post-Approval Clinical Study

Conditions
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Women Contraception

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At one and two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At one and two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adiana Permanent Contraception System, women seeking permanent sterilization.