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Adiana Post-Approval Clinical Study (APACS)

NCT ID: NCT01177670

Last Updated: 2012-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-04-30

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.

Conditions

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Women Contraception

Keywords

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Adiana Permanent Contraception System women seeking permanent sterilization.

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hologic, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Evantash, MD

Role: STUDY_DIRECTOR

Hologic, Inc.

Locations

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Sutter Medical Group

Elk Grove, California, United States

Site Status

WomenCare, P.C.

Arlington Heights, Illinois, United States

Site Status

University of Missouri Health Care

Columbia, Missouri, United States

Site Status

Valaoras & Lewis Obstetrics and Gynecology

Winston-Salem, North Carolina, United States

Site Status

Complete Healthcare for Women

Columbus, Ohio, United States

Site Status

The Women's Center of Central Oregon

Redmond, Oregon, United States

Site Status

Salem Women's Clinic

Salem, Oregon, United States

Site Status

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Ob/Gyn Associates of Danville

Danville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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S0210001

Identifier Type: -

Identifier Source: org_study_id