NCT01177670

Adiana Post-Approval Clinical Study (APACS)

Adiana Post-Approval Clinical Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Women Contraception

Timeline

• Start date: 2010-08-01
• Completion: 2012-04-01
• First posted: 2010-08-09
• Last updated: 2012-11-20
• Results posted: 2012-11-20

Locations

9 sites across 1 country: United States