The news article releases the results of a 'pilot' study and it looks like a well designed study, albeit a small one (only 14 patients). A pilot study is a smaller version of a clinical trial to tell the pharmaceutical company if spending all the money on a 'real' trial is worth it. Just like a 'pilot' for a TV show is a one or two episode teaser to see if anyone will watch it before the studios spend big money on making a whole season. But the study does look promising- hopefully it won't take them too long to perform and release the results.
At Fri, 10 Jan 2003, clareS wrote:
>
>Confluent Surgical, Inc. Announces Results of SprayGel(TM) Adhesion
>Barrier System U.S. Pilot Clinical Trial
>
>WALTHAM, March 1 /PRNewswire/ -- Confluent Surgical Inc. disclosed the
>results of its U.S. pilot clinical trial of its lead product,
>SprayGel(TM)
>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 clinical 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 <0.05).
>"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
>Dr. Alan Johns of the Texas Institute for Clinical Research, who was the
>principal investigator for the SprayGel study. Dr. Johns is also the
>President
>Elect of the American Association of Gynecological Laparoscopists.
>"This is an important milestone for Confluent, in the development of
>what
>promises to be the first truly effective therapeutic approach for the
>prevention of post-surgical adhesions. Adhesions formed as a result of
>endometriosis surgery and re-formation of adhesions to the ovaries and
>fallopian tubes are a huge problem. We are very excited by these initial
>results of SprayGel's strong efficacy in adhesion prevention in these
>procedures, which adds to the results we have previously seen in Uterine
>surgery from our European clinical trials," said Amar Sawhney, Ph.D.,
>Founder,
>President, and CEO of Confluent.
> Based on proprietary hydrogel technology, SprayGel consists of two
>synthetic liquids that when mixed together rapidly cross-link to form an
>absorbable biocompatible hydrogel in situ, at the application. The
>polymerization occurs very rapidly (within seconds) with no heat evolved
>and
>no external energy source required (e.g., liqht or heat source).
>SprayGel is
>sprayed onto tissues using an air-assisted sprayer that can be used in
>either
>laparoscopic or open laparotomy procedures. The hydrogel forms a
>flexible
>adhesion barrier that is tightly adherent to tissue, remains intact for
>about
>a week, and is then absorbed. This allows surgically injured tissues to
>heal
>without forming a scar or adhesion with surrounding organs. SprayGel has
>received the CE mark and is currently commercially available in select
>European countries. SprayGel is not currently approved for sale in the
>U.S.
>Confluent Surgical, Inc. is a privately held medical device company,
>that
>is focused on developing in-situ polymerized biomaterials to address
>unmet or
>under served clinical needs associated primarily with the prevention of
>Post
>Surgical Adhesions and Tissue Sealing. For more information, please
>visit
>http://www.confluentsurgical.com
>
>SOURCE Confluent Surgical Inc.
>Web Site: http://www.confluentsurgical.com
>
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