Adiana Post-Approval Clinical Study (APACS) (NCT01177670) | Clinical Trial Compass
TerminatedNot Applicable
Adiana Post-Approval Clinical Study (APACS)
Stopped: Hologic made business decision to no longer sell or manufacture Adiana device.
United States169 participantsStarted 2010-08
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.