If this is your first time posting to the IAS forum, welcome! All I could find to answer your question is the following post from Helen Dynda. I do hope it is of some assistance. Please feel free to ask your questions here, and we will do our best to help you. Good luck! Clare
MessageBoard
SprayGel? ... or ... Intergel? From: Helen Dynda (olddad66@runestone.net) Wed Oct 30 11:07:18 2002
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-------------------------------------------------------------------------------- SprayGel has NOT been approved by the FDA in the United States!! -------------------------------------------------------------------------------- SprayGel clinical trials are ongoing throughout the United States. If
-- -------------------------------------------------------------------------------- you are interested in being a participant in SprayGel clinical trial, who do you contact?The following information was sent to me regarding SprayGel clinical trials. If anyone is interested in becoming a participant in one of the clinical trials, the following email says
>>----- Original Message -----
From: "Scerbin, Vladimir" <vscerbin@confluentsurgical.com> To: <olddad66@runestone.net> Sent: Tuesday, October 29, 2002 12:54 PM Subject: PREVAIL
Helen,
I received the e-mail that you sent to Bobby Sawyer. We are restricted by Federal regulations to give out the investigational centers. However, if you have potential patients who are interested in the study, feel free to give them my contact information and I will be more than gald to speak to them about the study and direct them to the closest PREVAIL investigator. If you have any further questions, feel free to contact at my direct telephone below:
Vladimir Ian Scerbin Jr. Director, Clinical Affairs Confluent Surgical Inc. 101A First Avenue Waltham, MA 02451 Tel: (781) 693-2305 Fax: (781) 693-2331 Cell: (781) 929-8926
-- SprayGel is available in the following countries only:Australia
Europe
United Kingdom
At Fri, 10 Jan 2003, Kathi wrote: > >At Fri, 10 Jan 2003, clareS wrote: >> >>I found this on the obgyn.net news site. >>Clare >> >>First procedure performed in U.S. trial for SprayGel Adhesion Barrier >>Adhesions >>August 1, 2002 >>2002 AUG 1 - (NewsRx.com & NewsRx.net) -- Confluent Surgical, Inc., >>announced the commencement of its pivotal U.S. trial for the SprayGel >>Adhesion Barrier in Prevention of Pelvic Adhesions In Laparoscopic >>Surgery, the PREVAIL Study. Confluent Surgical believes that the >>SprayGel Adhesion Barrier will prevent and reduce adhesions that are >>associated with severe postoperative pain and other side effects, which >>affect millions of women annually. >> >>The first procedure in the PREVAIL Study was performed by Michael L. >>Twede, MD, FACOG, and Dale A. Sundwall, MD, FACOG, Medical Directors at >>the Salt Lake City Women's Center. Twede and Sundwall are considered >>experts in the treatment of endometriosis and adhesions and are >>respected as highly skilled surgeons. >> >>Twede states, "Based on the early published results, SprayGel appears to >>represent a breakthrough in adhesion prevention. It is unique in its >>ability to be applied laparoscopically and remain in place as a barrier >>for five to seven days, the period when adhesions normally form. If the >>results from the initial pilot study are replicated in this pivotal >>study, this product would prevent or significantly reduce patient trauma >>and costs associated with additional surgery for adhesions." >> >>Adhesions are fibrous bands of tissue between adjacent organs of the >>body. They typically occur as a result of inflammation incident to >>surgery and can cause severe pelvic pain and infertility. Adhesions >>start to form within three hours of surgery and will cease forming when >>the surgical sites heal, usually within 7 days following surgery. The >>SprayGel Adhesion Barrier is designed to protect the tissues during this >>critical healing period. It is estimated that adhesions affect over two >>million women and men in the U.S. and that the potential U.S. market >>for abdominopelvic adhesion management is $400-$500 million. >> >>"Based on its early performance in prior pilot trials as well as our >>early commercial success in Europe, we believe that SprayGel will become >>the product of choice for gynecologic surgeons to prevent postoperative >>adhesions," stated Amar S. Sawhney, president and CEO of Confluent >>Surgical, Inc. This article was prepared by Women's Health Weekly >>editors from staff and other reports. >> >>©Copyright 2002, Women's Health Weekly via NewsRx.com & NewsRx.net >> >>Click here for additional articles on Preventive Medicine >> >> return to OBGYN.net Headline News ... (2001 archives) > >-- >How can one get into these clinical trials? >