revision clinical trial

Hi all.  Just wanted to let you all know I am in a clinical trial for a product called Endocinch (TM.) The Product is uesed approved by the FDA for treating GERD. (gastric reflux) and the company wants FDA approval for revision to gatric bypass pt with regain or inadequet weigtloss after gastric bypass. Dr. Christpher Thompson MD. Is the pioneer for Transoral surgery for things like gall bladder GERD and other GI problems. HE is the Principal investigator for study at Brighams and womens Hosp. in Boston but there are other hosp. that are doing it here is the  addy  :http://clinicaltrials.gov/ct/show/NCT00394212?order=1       This is a trial so you dont know if you had the procedure or not BUT if you did not have it in 6 months you can have it at no cost. This procedure to me sounds like what stomaphynx is. Hope this can help someone

I had this procedure by Dr. Thompson in Boston a year ago.  he can only tighten the stoma and cannot do the pouch.  It is nothing like the stomaphyx, he does  go in through your mouth and then stitches your stoma,  it worked for about 6 months, I lost 40 pounds and it does not work any longer.  I am going for a complete revision now with Dr. Overcash in Ocala. Unless Dr. Thompson does the pouch also, I wouldn't waste my time.  Staples are used for the stomaphyx and both the pouch and stoma are done, with the Endocinch he was only doing the stoma unless he has the item to do the pouch, he didn't have it last July when I was there. it was really a big thing last year, but the stomaphyx is suspose to be the best revision for the money and works almost like the original surgery. Good luck, hope it works for you.

Donna, You mentioned have a revision with Dr. OverCash.  I am having a revision with him next month myself.  Are you having a full revision as in being opened up?  I am having the open RNY.  My previous surgery was the mini-gastric bypass.  When I told him I had this surgery he told me that I did not need the stomaphx but I need to be revised to the RNY.  I hear he has a good reputation and I am praying this surgery be last surgery for weight loss that I will ever need.  I can't emotionally handle another failure.

I don't have a date yet, just sent into my insurance to get approval, I have the coverage, but right now I have to jump through hoops, they hope that I will just shrivel up and blow away. Dr. Overcash said I need a complete revision, my intestine was done distal, hardly any malabsorbition, the stoma  and pouch are very large.  My pouch was original a 50cc so you know it is large now after 5 years, the stoma was done last year by Dr. Thompson, but that has quit working, the stitches have probably come undone.  I kept hearing about beng a light weight by my original doctor, and they made me like that, hardly any tool to work with.  I only lost a total of 31 pounds from the original surgery and 40  from the stoma stitching,of course i gained it all back and then some. Doctor Overcash is suppose to be one of the best for revisions.  I sure hope this is  the last surgery for me.  I just need one good tool to work at least a couple of years to get me going on the weight loss i need. Guess I will be open this time, he said just a small one for the intestine, and then i could go the stomaphyx for the pouch and stoma. Good luck, let me know how it all goes.

I understand that Dr. Overcash just did his first DS surgery. Maybe consider a revision to the DS...it's done a lot but the surgeon must be experienced.

Dianne from FL

I know what you are saying and I am with you, but this is a trial and you dont pay for anything, thay pay you and for me its the best option since I cant pay the $$$$. That is why I thought I would share it so if someone can bennifit. I would like to also add that he does now do the pouch but not for the study pupose. My pouch is large about 6cm lonf and 3 cm wide. my stoma is 35mm. I am opting for this study and he said I could get a "Tune up" later on or even have my pouch done. In any case I hope that It works well and If it doent then i will have lost nothing(hahhaha) but time.

Thank you so much for posting this!!  I'm really trying to avoid having major surgery again and this COULD just help me.  I'm going to contact them on Monday.  Thanks again!!!!

I found another link that has a little more information about this-including a phone number: http://www.brighamandwomens.org/gastroenterology/gastricbypa ss.aspx

Thank you for your post. I will contact this MD on Monday. I was evaluated for StomaphyX and it was determined that I was not a candidate because my pouch is too small. My anastomosis was overdilated at 4 months post-op by an inexperienced MD. Maybe this will bbe an option for me. Do you know anything about the procedure? Do the sutures hold? Thanks for the info.

You are very welcome! This is a very new and not yet approved type of revsion not to MUCH diffrent from Stomaphynx. The Big Diffrence is they use real sutures and not plastic type staples.I must express thay this IS a CLINICAL TRIAL. that thay are doing to get FDA approval. Thre are no long term data diffrent then the stomaphynx. I feel that since there are no long term stats on any  post op weight loss procedures. I didnt think I WOULD BE even trying or nedding to try something elece 3 years ago when I had RNY. I am 5 days post op and feel great...Iam on liqids only for 16 days total and that is a little tuff but I am determined to do this 100 % for myself and the study sake. I ahve truly learned alot about myself in the last week about my hunger/ food issues. I am looking forward to seeing how things will be with solid food, belive me! I hope you find the right path on the new chapter in your journey. take care   KIM