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Fallopian Tube Device Gets High Marks From Patients.
2001 APR 19 - (NewsRx.com & NewsRx.net) -- Conceptus. Inc. (CPTS), developer of the Stop[TM] (Selective Tubal Occlusion Procedure) non-surgical permanent birth control device for women, announced that the first interim review of data from the Stop pivotal trial found a reduction in average procedure time, an increase in the rate of placement in both fallopian tubes (bilateral placement), and a decrease in the adverse event rate, when compared with interim data from the Phase II study as of March 23, 2001.
At the 10th Annual Congress of the International Society for Gynecologic Endoscopy (ISGE), held in Chicago, Illinois, John Kerin, MD, with the Ashford Community Hospital, Adelaide, Australia, and a clinical investigator in the Stop trial, presented preliminary data from the pivotal trial in which a total of 518 women were enrolled.
Kerin noted that when compared with the Phase II study, in which 227 women were enrolled, the pivotal trial has shown a 28% reduction in average procedure time to 13 minutes from 18 minutes and that the bilateral placement rate has improved to 90% from 88%. Using combined data from the pivotal trial and the Phase II study, more than 650 women have had bilateral placement of Stop devices. Adverse events, which consisted primarily of events associated with improper placement, have decreased to 3.3% from 5.3%.
Patient tolerance with the placement procedure and subsequent use continues to be highly rated by patients. In the pivotal trial and the Phase II study, nearly 90% of women who had devices placed rated their tolerance of the procedure as "good" to "excellent." Additionally, women in the on-going Phase II study have accumulated more than 3,300 woman-months of use of the Stop device, and among women who have completed the three-, six-, 12-, or 18- month follow-up exams, 99% rated their satisfaction as "good," "very good," or "excellent."
"We are encouraged by this newest data which confirms and strengthens the results from the Phase II study, said Jay M. Cooper, MD, founder and medical director of Women's Health Research Center, Phoenix, Arizona, ...
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Source: HighBeam Research, Fallopian Tube Device Gets High Marks From Patients.