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Article: Patient Enrollment Goal Met for Tubal Occlusion Trial.(Conceptus Inc. tests Selective Tubal Occlusion Procedure)
- Article from:
- Women's Health Weekly
- Article date:
- January 25, 2001
- Author:
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2001 JAN 25 - (NewsRx.com) -- Conceptus, Inc., announced that bilateral placement has been achieved in more than 400 patients in the pivotal clinical study of the STOP [TM] (Selective Tubal Occlusion Procedure) non-surgical permanent contraception device for women.
The pivotal study is designed to obtain 12-month effectiveness data on 400 patients with bilateral placement to support a Pre-Market Approval (PMA) application. Accordingly, the PMA application filing timeline is expected to be accelerated by approximately three months.
Enrollment in the multi-center, international pivotal clinical trial for STOP commenced in May of 2000. Additional patients ...