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Patient Enrollment Goal Met for Tubal Occlusion Trial.(Conceptus Inc. tests Selective Tubal Occlusion Procedure)
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 will continued to be enrolled to replace any patients who may be lost-to-follow-up or who cannot be evaluated for other reasons. The pivotal trial will examine safety, effectiveness, and patient comfort during the placement procedure and subsequent use of the STOP device.
"The rapid enrollment we've experienced in the STOP trial highlights the desire women have for a new permanent contraceptive option, and demonstrates the tremendous commitment of the physicians and their staffs at all of the investigational sites," said Jay M. Cooper, MD, Women's Health Research Center, Phoenix, Arizona, and the principal U.S. investigator of STOP.
The pivotal study protocol requires 12 months of follow-up after each patient begins to ...
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- Press release article from: PR Newswire March 29, 1988 700+ words
...APPROVES CABOT MEDICAL'S TUBAL OCCLUSION SYSTEM LANGHORNE, Pa., March...for the Falope-Ring Band tubal occlusion system. According to Warren G. Wood, president, Cabot's tubal occlusion device is the only approved...
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- Press release article from: PR Newswire November 16, 1987 700+ words
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The Falope-Ring[R] Band System is a highly efficacious laparoscopic method for tubal occlusion. The Falope-Ring Band is an inert radiopaque silicone band that is applied to a looped section of the Fallopian tube with the...
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- Press release article from: Business Wire February 3, 1997 700+ words
...the United States Food and Drug Administration (FDA) to market its STARRT Falloposcopy System for diagnosis of proximal tubal occlusion (PTO), a blockage of the fallopian tube which is a known cause of infertility. The Selective Tubal Assessment to Refine...
Source: HighBeam Research, Patient Enrollment Goal Met for Tubal Occlusion Trial.(Conceptus Inc....