Adiana Post-Approval Clinical Study (APACS)

NCT01177670 | Terminated Results

• 1 other identifier: S0210001
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 9

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.

Conditions

Women Contraception

Keywords

Adiana Permanent Contraception System; women seeking permanent sterilization.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety Endpoints

  At one and two years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (9)

Sutter Medical Group

Elk Grove, California, 95758, United States

Location

WomenCare, P.C.

Arlington Heights, Illinois, 60004, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65203, United States

Location

Valaoras & Lewis Obstetrics and Gynecology

Winston-Salem, North Carolina, 27103, United States

Location

Complete Healthcare for Women

Columbus, Ohio, 43231, United States

Location

The Women's Center of Central Oregon

Redmond, Oregon, 97756, United States

Location

Salem Women's Clinic

Salem, Oregon, 97302, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Ob/Gyn Associates of Danville

Danville, Virginia, 24541, United States

Location

Limitations and Caveats

After determining Adiana was not financially viable and would not become so, Hologic decided to discontinue manufacturing \& sales. Hologic decided to terminate the study. All subjects were notified of termination and withdrawn by April 30, 2012.

Results Point of Contact

• Title: Edward Evantash, MD
• Organization: Hologic, Inc.

edward.evantash@hologic.com

508-263-8475

Study Officials

• Edward Evantash, MD

  Hologic, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 9, 2010
• Study Start: August 1, 2010
• Study Completion: April 1, 2012
• Last Updated: November 20, 2012
• Results First Posted: November 20, 2012

Record last verified: 2012-10

Locations

US (9)