Adiana Post-Approval Clinical Study (APACS) (APACS)

• ClinicalTrials.gov Identifier: NCT01177670
• Recruitment Status: Terminated
• First Posted: August 9, 2010
• Results First Posted: November 20, 2012
• Last Update Posted: November 20, 2012
• Sponsor: Hologic, Inc.
• Information provided by (Responsible Party): Hologic, Inc.

Study Description

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. 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.

Condition or disease
Women Contraception

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 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 Design

• Study Type: Observational
• Actual Enrollment: 169 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Adiana Post-Approval Clinical Study
• Study Start Date: August 2010
• Actual Study Completion Date: April 2012

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception. [ Time Frame: At one and two years ]
   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.

Secondary Outcome Measures :

1. Safety Endpoints [ Time Frame: At one and two years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Women, 18 - 45 years old, at risk for pregnancy, that are seeking permanent contraception using the Adiana Permanent Contraception System.

Criteria

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

Contacts and Locations

Locations

United States, California

Sutter Medical Group

Elk Grove, California, United States, 95758

United States, Illinois

WomenCare, P.C.

Arlington Heights, Illinois, United States, 60004

United States, Missouri

University of Missouri Health Care

Columbia, Missouri, United States, 65203

United States, North Carolina

Valaoras & Lewis Obstetrics and Gynecology

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

Complete Healthcare for Women

Columbus, Ohio, United States, 43231

United States, Oregon

The Women's Center of Central Oregon

Redmond, Oregon, United States, 97756

Salem Women's Clinic

Salem, Oregon, United States, 97302

United States, Pennsylvania

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States, 15224

United States, Virginia

Ob/Gyn Associates of Danville

Danville, Virginia, United States, 24541

Sponsors and Collaborators

Hologic, Inc.

Investigators

• Study Director: Edward Evantash, MD; Hologic, Inc.

More Information

• Responsible Party: Hologic, Inc.
• ClinicalTrials.gov Identifier: NCT01177670
• Other Study ID Numbers: S0210001
• First Posted: August 9, 2010
• Results First Posted: November 20, 2012
• Last Update Posted: November 20, 2012
• Last Verified: October 2012

Keywords provided by Hologic, Inc.:

Adiana Permanent Contraception System; women seeking permanent sterilization.