Confluent Surgical announces results of SprayGel adhesion barrier system pilot clinical trial.(Brief Article)

2002 APR 4 - (NewsRx.com & NewsRx.net) -- Confluent Surgical, Inc., disclosed the results of its U.S. pilot clinical trial of its lead product, SprayGel Adhesion Barrier at the VIIth World Congress on Endometriosis in San Diego.

SprayGel is designed to reduce or eliminate adhesions after gynecological surgery. Adhesions are a leading cause of pain, infertility, and other complications following such surgery.

The pilot clinical study was conducted at two sites in the U.S., and consisted of 14 randomized patients undergoing surgery for removal of endometriosis and adhesions on the uterine adnexa, such as the ovaries and fallopian tubes. The endpoints of the internally controlled clinical trial examined the reduction in incidence and extent of adhesions to the adnexa. The incidence of adhesion formation to the SprayGel treated adnexa was found to be 71% reduced at the time of second look surgery, over that of the contralateral control adnexa, relative to initial surgery. The extent of adhesion formation was reduced by 69%. Both differences were found to be statistically significant (p

"I was impressed by the level of performance that we saw with SprayGel in this group of patients that underwent extensive surgery for advanced endometriosis and presence of adhesions. I have been involved in many clinical trials for adhesion prevention to date, and I find the approach that SprayGel takes to solving this problem as a very promising one. I am looking forward to participating in the Pivotal Clinical study for this exciting product," said Alan Johns of the Texas Institute for Clinical Research, who was the principal investigator for the SprayGel study. Johns is also the president elect of the American Association of Gynecological ...