Status:
TERMINATED
Adiana Post-Approval Clinical Study (APACS)
Lead Sponsor:
Hologic, Inc.
Conditions:
Women Contraception
Eligibility:
FEMALE
18-45 years
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. Specificall...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT01177670
Start Date
August 1 2010
End Date
April 1 2012
Last Update
November 20 2012
Active Locations (9)
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1
Sutter Medical Group
Elk Grove, California, United States, 95758
2
WomenCare, P.C.
Arlington Heights, Illinois, United States, 60004
3
University of Missouri Health Care
Columbia, Missouri, United States, 65203
4
Valaoras & Lewis Obstetrics and Gynecology
Winston-Salem, North Carolina, United States, 27103