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General |
Study Status |
Terminated |
Application Number / Requirement Number |
P070022 / PAS001 |
Date Original Protocol Accepted |
07/06/2009
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Date Current Protocol Accepted |
07/06/2009
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Study Name |
EASE TRIAL
|
Device Name |
ADIANA PERMANENT CONTRACEPTION SYSTEM
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
This study is a continued follow-up of subjects in the premarket EASE trial, a prospective, single-armed, multicenter study. The primary objective of the post-approval study is to determine the 3-year through 10-year, yearly period efficacy rates for subjects enrolled in the premarket EASE study.
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Study Population |
The device is indicated for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes. The study population includes women who are currently relying on the Adiana system for permanent contraception and those who are being followed for safety purposes, all from the premarket cohort.
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Sample Size |
770 patients, 16 sites
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Key Study Endpoints |
Effectiveness endpoint is the pregnancy rate during the three through ten year reliance follow-up period for subjects in the EASE study who rely on the device for contraception.Safety endpoints include: (1) Subject satisfaction and comfort with device wearing; (2) Safety of device wearing; and (3) Relevant adverse events: All reproductive adverse events, and all abdominal adverse events reported during the study.
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Follow-up Visits and Length of Follow-up |
All subjects will be assessed annually in years 3, 4, 5, 6, 7, 8, 9 and 10 post reliance or follow up date (±30 days). All visits will occur via telephone. If there is any indication that the subject may be pregnant, by either verbal admission or unusual menstrual events, an office visit will be scheduled and a pregnancy test administered within one month. The duration of follow-up is ten years.
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