Clinical trial NCT01177670: Adiana Post-Approval Clinical Study (APACS)
Official title: Adiana Post-Approval Clinical Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Women Contraception
Keywords: Adiana Permanent Contraception System
women seeking permanent sterilization.
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 169
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Pregnancy Rate - for Women Informed They May Rely on the Adiana System for Contraception.
timeFrame: At one and two years
Secondary outcomes:
measure: Safety Endpoints
timeFrame: At one and two years
Other outcomes:
Locations:
city: Elk Grove
country: United States
facility: Sutter Medical Group
state: California
city: Arlington Heights
country: United States
facility: WomenCare, P.C.
state: Illinois
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Winston-Salem
country: United States
facility: Valaoras & Lewis Obstetrics and Gynecology
state: North Carolina
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Redmond
country: United States
facility: The Women's Center of Central Oregon
state: Oregon
city: Salem
country: United States
facility: Salem Women's Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Ob/Gyn Associates of Danville
state: Virginia
Study officials:
affiliation: Hologic, Inc.
name: Edward Evantash, MD
role: STUDY_DIRECTOR
References: