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

Adiana Post-Approval Clinical Study

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.

Study Overview

• Status: Terminated
• Conditions: 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 Type: Observational
• Enrollment (Actual): 169

Contacts and Locations

Study Locations

• United States
  • California
    • Elk Grove, California, United States, 95758
      • Sutter Medical Group
  • Illinois
    • Arlington Heights, Illinois, United States, 60004
      • WomenCare, P.C.
  • Missouri
    • Columbia, Missouri, United States, 65203
      • University of Missouri Health Care
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Valaoras & Lewis Obstetrics and Gynecology
  • Ohio
    • Columbus, Ohio, United States, 43231
      • Complete Healthcare For Women
  • Oregon
    • Redmond, Oregon, United States, 97756
      • The Women's Center of Central Oregon
    • Salem, Oregon, United States, 97302
      • Salem Women's Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Western Pennsylvania Hospital
  • Virginia
    • Danville, Virginia, United States, 24541
      • Ob/Gyn Associates of Danville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints	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.	At one and two years

Collaborators and Investigators

• Sponsor: Hologic, Inc.
• Investigators: Study Director: Edward Evantash, MD, Hologic, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (Estimate): August 9, 2010

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: October 19, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Adiana Permanent Contraception System; women seeking permanent sterilization.
• Other Study ID Numbers: S0210001