Re: sults of SprayGel U.S. Pilot Clinica Trial - for Dr. Moore

From: jason h rachal (arshal@juno.com)
Fri Jan 10 15:00:07 2003


dr. moore, i have been reading alot from this site for awhile. i have kept my mouth shut, and if you ask my dr. he would tell you different. that its my mouth that has kept me alive.lol i see you have upset alot of women on here..and these we women and me are not trying to argue that your a bad or "one of those dr" we just need someone who is going to take the time to listen and learn and not be to quick to judge. i know adhesions by themselves dont cause the pain and so do these ladies but we do know what they do to our organs and body functions from day to day and i know you do to, and many like they have told you dont have support from anywhere else.. we are definetly not trying to be a dr.. just a caring and compassionate friend..

you have to understand that going from dr. to dr. and let down so much can cause emotional pain. and that is what most of these ladies and me have..

now today is a new day you have came back with a better attitude and i myself and i know the other ladies appreciate you coming back to help.. its the little things that help us feel better. not the truely big ones.. because we all live including yourself from day to day..

my own opinion is if most dr. would actually take the time to learn more from their patients and actually listen and not run them off, you would get a better understanding of what we go threw, on a more compassionate level to speak.. i am not saying you dont personally do that because i dont truely know you, but i do know some who do..

my dad has a incurable brain tumor and disease called men2, and about 17yrs ago when he was first diagnosed with this they told him they did not know much about it and even the medical books could not help.. but he had one dr. from baylor med. in houston,tx who took the time to gather all his students and other dr. friends and brought my mom and my dad in a room (over 100people) and decided they wanted to talk to him and her and learn all the little things about them all the way down to intimacy... after doing this the drs. started learning alot more about this disease and are still trying to find ways to cure it..all i am saying is not all medical books will give you the right answer, you need the patients help also.. and if your not compassionate you will lose out on what could be the best resource ever known.....

i thank you for taking the time to email and talk to all of us..and its ok to be skeptic about things, just dont put it out of your mind for good.. this is the only way to learn more about things you never knew of.. and you are right until it is proven at 100% effective who knows what could happen. but dont put anyone down that has tried. that is just not a good thing to do.. you are young like me (30) and have alot of good sense and you never know you may be one yourself to bring something to help millions of people around the world. that is why we count on drs. such as yourself... because we need more knowledge just as you do to learn about our diseases..

thank you, and keep coming here and learning and educating us and yourself...

your friend nicky On Fri, 10 Jan 2003 14:26:46 -0600 bbm1969@bellsouth.net (Dr.Moore) writes: > Now this is truly good news. I will have to say I am a skeptic
> about
> such trials only because we in the medical community have had our
> hopes
> dashed many times before with the supposed next 'cure' for
> adhesions. I
> keep referring to Intercede, which was the most current snake oil
> when I
> was in training. Others of you have mentioned Integrel and the
> medical
> literature lists all kinds of others. None have been shown to be
> effective so far. I hope Spraygel is- but again, until it is
> proven, I
> won't use it.
>
> 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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> >
>
> http://www.adhesions.org/forums/listcmds.htm
>


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