Stretta procedure
Question:
I’m being asked to participate in a study with an experimental procedure for my GERD.The procedure is being researched at two different colleges, U of Mich and Stanford. U of M has only done a couple, stanford has done this over 20 times (which still isn’t many). They stick a tube down you and cook your sphincter with rf waves. They do it by running a tube down you (like an EDG). I’m leaning towards saying no. My EDG was normal and my manometry showed no hernia. i’m thinking that there has to be a better solotution than letting folks play with my innards. thoughts? Jimmy
Response:
You did not mention if you have had a 24 hour Ph probe? Are you under control using medication? If so, what and how much? Heartburn and Gastro Esophageal Reflux web page: http://www.heartburn-help.com
Response:
> They stick a tube down you and cook your sphincter with rf waves.
This sounds interesting. What advantage is there to having a cooked sphinter? Alex.
Response:
>You did not mention if you have had a 24 hour Ph probe? Are you under control >using medication? If so, what and how much?
I did have the ph probe done, while I was taking medication. Prilosec 20mg, twice a day.
Response:
>This sounds interesting. What advantage is there to having a cooked >sphinter?
The current surgical option uses part of your stomach muscle to support the sphincter. The rf waves scar the muscke to make it more difficult to open inadvertantly and spray acid up your GI tract.
Response:
Does this scarring of the sphincter muscle caused by the Stretta procedure then make it more difficult to burp and swallow also? -Chris >This sounds interesting. What advantage is there to having a cooked >sphinter? > The current surgical option uses part of your stomach muscle to support the > sphincter. The rf waves scar the muscke to make it more difficult to open > inadvertantly and spray acid up your GI tract.
Response:
Thank you for posting about this experimental procedure. I think the advantage might be for someone who is considering having the fundopulcation surgery and who has exhausted other treatment options or can’t utilize other treatment options. I think if it is a valid procedure thatit might be something that I would want to check out since I am not comfortable using meds to supress all acid production in my stomach due to fear of increased risk of food poisoning, but I know I couldn’t tolerate the current surgery even if it was done with a laproscope. I can’t take post op pain meds so I have surgery done only as a last ditch life saving procedure. I might be able to cope with the Stretta Procedure. Please ask the physicians to post about this procedure on this news group when they get results or to point us to studies and papers written on the procedure so we can find out more. -Chris – Hide quoted text — Show quoted text -> I’m being asked to participate in a study with an experimental procedure for my > GERD.The procedure is being researched at two different colleges, U of Mich and > Stanford. U of M has only done a couple, stanford has done this over 20 times > (which still isn’t many). > They stick a tube down you and cook your sphincter with rf waves. They do it by > running a tube down you (like an EDG). > I’m leaning towards saying no. My EDG was normal and my manometry showed no > hernia. i’m thinking that there has to be a better solotution than letting > folks play with my innards. > thoughts? > Jimmy
Response:
>Does this scarring of the sphincter muscle caused by the >Stretta procedure then make it more difficult >to burp and swallow also
I don’t know–but I’ll ask when I meet with the docs on Friday. Jimmy
Response:
>Please ask the physicians to post about this procedure on this >news group when they get results or to point us to studies and >papers written on the procedure so we can find out more
They are suppsoed to give me some information about this on Friday. I’ll post whatever it is they give me. The procedure is being researched at Stanford and the University of Michigan. Stanford has done the procedure 21 times. U of M has done it twice, they’d like to make me number 3. I’m going to turn this down. When they did my EDG scope they didn’t find any damage. I don’t feel any need to rush into any sort of surgical procedure. My mind is about 90% decided against this, but I’m still going to listen to what they have to say. Jimmy
Response:
This was announced in BW HealthWire: Hope Is On the Horizon for 14 Million Sufferers of “GERD”: Stretta Procedure by Conway Stuart Medical SUNNYVALE, Calif.–(BW HealthWire)–May 4, 1999–"GERD" is an acronym that reflects in sight and sound its origin, gastroesophageal reflux disease: heartburn to the max and perhaps even worse. It currently afflicts more than 14 million Americans and the number is rising. GERD results when acidic stomach contents "reflux" up into the esophagus, causing severe heartburn, regurgitation, chronic cough and other symptoms. Until now, only two treatments have been available and both are costly — medication, which can be required on a daily basis, and surgery, which requires hospitalization and a lengthy recovery period. Now a third, potentially better alternative is on the horizon. A new procedure that takes only about 40 minutes, is performed on an outpatient basis at a cost approximating a year’s supply of medication. It is known as the Stretta(TM) Procedure and early clinical trials point to major impacts on symptoms and medication requirements. Stretta(TM) Procedure developers believe that if further clinical data proves positive, the procedure could be available to the general public before the end of the year. The new procedure is the brainchild of Conway Stuart Medical Inc., Sunnyvale, founded by Stuart Edwards, and David S. Utley, M.D., a surgeon at the VA Palo Alto Health Care System/Stanford. The Stretta System(TM) consists of a thermal power module and a flexible catheter. This nonsurgical intervention delivers heat energy to the valve between the esophagus and the stomach, which is weakened in patients with GERD. This procedure is believed to tighten the valve and increase resistance to reflux. To this point, 30 patients have been treated at Stanford. Additional clinical sites throughout the United States will begin using the Stretta System(TM) in the near future. Two foreign sites will be underway in Australia and Germany shortly. At the same time, Conway Stuart is taking necessary steps to assure that the new procedure will be accepted by major insurance carriers and Medicare. A recent article in the New England Journal of Medicine reports that GERD, even when treated with medication, can lead to an increased risk of esophageal cancer. Stories in the New York Times (April 27, 1999) and Time Magazine (April 26, 1999) report that Swedish researchers have proven that inadequately treated heartburn substantially increases the risk of cancer. And that among study participants who had particularly severe and long-standing heartburn, the risk of cancer rose by 43.5 times. The U.S. Food and Drug Administration has cleared the Stretta System(TM) for use in coagulating tissue. An FDA submission seeking clearance to promote the Stretta System(TM) for special GERD indications is currently pending. Although GERD is rarely fatal, it ranks almost at the top of ailments that impact quality of life, topped only by psychiatric disease. For more information on the Stretta(TM) Procedure or the company, contact Carol Chludzinski, vice president Sales & Marketing, Conway Stuart Medical Inc., 735 Palomar Ave., Sunnyvale, Calif., 94086; telephone 408/733-9910; fax NOTE TO EDITORS: To arrange an interview, contact Harriet Berner at 650/473-9393. Photos are available upon request. –30–MT/la* LES/la CONTACT: Public Communications/West Harriet Berner, 650/473-9393 Heartburn and Gastro Esophageal Reflux web page: http://www.heartburn-help.com
Response:
I think you are right to not do anything you feel uncomfortable doing. If you have no damage, I would think you are not in a desperate situation. My fear is that by scarring the sphincter muscle that it would be harder to burp and swallow. That’s like trading one digestive problem for another one. I’m just interested in getting as much information as possible to know what the options and risks are. Thanks. -Chris – Hide quoted text — Show quoted text ->Please ask the physicians to post about this procedure on this >news group when they get results or to point us to studies and >papers written on the procedure so we can find out more > They are suppsoed to give me some information about this on Friday. I’ll post > whatever it is they give me. The procedure is being researched at Stanford and > the University of Michigan. Stanford has done the procedure 21 times. U of M > has done it twice, they’d like to make me number 3. > I’m going to turn this down. When they did my EDG scope they didn’t find any > damage. I don’t feel any need to rush into any sort of surgical procedure. My > mind is about 90% decided against this, but I’m still going to listen to what > they have to say. > Jimmy
Response:
Thank you HawkTear. Although it’s been horrible for you, you getting reflux has been a blessing to so many others because of all the work you do to get information out to people. -Chris – Hide quoted text — Show quoted text -> This was announced in BW HealthWire: > Hope Is On the Horizon for 14 Million Sufferers of “GERD”: Stretta Procedure > by Conway Stuart Medical > SUNNYVALE, Calif.–(BW HealthWire)–May 4, 1999–"GERD" is an acronym that > reflects in sight and sound its origin, gastroesophageal reflux disease: > heartburn to the max and perhaps even worse. > It currently afflicts more than 14 million Americans and the number is > rising. GERD results when acidic stomach contents "reflux" up into the > esophagus, causing severe heartburn, regurgitation, chronic cough and other > symptoms. > Until now, only two treatments have been available and both are costly — > medication, which can be required on a daily basis, and surgery, which > requires hospitalization and a lengthy recovery period. > Now a third, potentially better alternative is on the horizon. A new > procedure that takes only about 40 minutes, is performed on an outpatient basis > at a cost approximating a year’s supply of medication. > It is known as the Stretta(TM) Procedure and early clinical trials point > to major impacts on symptoms and medication requirements. Stretta(TM) Procedure > developers believe that if further clinical data proves positive, the procedure > could be available to the general public before the end of the year. > The new procedure is the brainchild of Conway Stuart Medical Inc., > Sunnyvale, founded by Stuart Edwards, and David S. Utley, M.D., a surgeon at > the VA Palo Alto Health Care System/Stanford. > The Stretta System(TM) consists of a thermal power module and a flexible > catheter. This nonsurgical intervention delivers heat energy to the valve > between the esophagus and the stomach, which is weakened in patients with GERD. > This procedure is believed to tighten the valve and increase resistance to > reflux. > To this point, 30 patients have been treated at Stanford. Additional > clinical sites throughout the United States will begin using the Stretta > System(TM) in the near future. Two foreign sites will be underway in Australia > and Germany shortly. At the same time, Conway Stuart is taking necessary steps > to assure that the new procedure will be accepted by major insurance carriers > and Medicare. > A recent article in the New England Journal of Medicine reports that GERD, > even when treated with medication, can lead to an increased risk of esophageal > cancer. > Stories in the New York Times (April 27, 1999) and Time Magazine (April > 26, 1999) report that Swedish researchers have proven that inadequately treated > heartburn substantially increases the risk of cancer. And that among study > participants who had particularly severe and long-standing heartburn, the risk > of cancer rose by 43.5 times. > The U.S. Food and Drug Administration has cleared the Stretta System(TM) > for use in coagulating tissue. An FDA submission seeking clearance to promote > the Stretta System(TM) for special GERD indications is currently pending. > Although GERD is rarely fatal, it ranks almost at the top of ailments that > impact quality of life, topped only by psychiatric disease. > For more information on the Stretta(TM) Procedure or the company, contact > Carol Chludzinski, vice president Sales & Marketing, Conway Stuart Medical > Inc., 735 Palomar Ave., Sunnyvale, Calif., 94086; telephone 408/733-9910; fax > NOTE TO EDITORS: To arrange an interview, contact Harriet Berner at > 650/473-9393. Photos are available upon request. > –30–MT/la* LES/la > CONTACT: > Public Communications/West > Harriet Berner, 650/473-9393 > Heartburn and Gastro Esophageal Reflux web page: http://www.heartburn-help.com
Response:
Chris asked: >Does this scarring of the sphincter muscle caused by the >Stretta procedure then make it more difficult >to burp and swallow also?
This is one of the concerns they had. What the procedure does is cook the sphincter. The literally heat it up and tighten all the tissue around the muscle (to get a better seal). Because my sphincter muscle was strong they weren’t worried about this side effect. The also liked the shape of my sphincter and the fact that it appeared to be loose in a "normal" sort of way. My physiology indicated that I was a good candidate for a research patient. I told them no thanks. They fully supported my decision. I was told to feel free to use over the counter antacids to supplement the prescription meds as needed. With regards to the 43.5 times greater cancer risk stat … I asked my doctor about this. My concern was that this line in the press release was a scare tactic to help sell the procedure. My doctor agreed that this stat (while true) is meaningless. It is still a number well below 1% of the population. Keep in mind that about a third of the population has some kind of reflux and the number is still very, very small . They have done Stretta 25 times now (I would have been #26) and the results so far look about 80% effective. What they don’t know is how long the benefits will last after the surgery. When the procedure has been successful, the patient has been able to dramatically cut back medication or eliminate it completely. The results they are looking at are less than a year old–less than a handful are more than six months. They didn’t give me any written information on the procedure. 
Jimmy
Response:
Dear Jimmy: Thank you so much for providing this information to me and to the others on this group. It would be wonderful if they could come up with a procedure that could help without leaving other troublesome problems behind and without major surgery. If you learn any more, please let us know. I think you are wise to wait and give this more time. It’s not like you are at the end of your rope with the gerd at this point or like you are running out of viable options. Every day you get through research will continue and there is the hope of new procedures or even a total cure. Thanks again. – Chris – Hide quoted text — Show quoted text -> Chris asked: >Does this scarring of the sphincter muscle caused by the >Stretta procedure then make it more difficult >to burp and swallow also? > This is one of the concerns they had. What the procedure does is cook the > sphincter. The literally heat it up and tighten all the tissue around the > muscle (to get a better seal). > Because my sphincter muscle was strong they weren’t worried about this side > effect. The also liked the shape of my sphincter and the fact that it appeared > to be loose in a "normal" sort of way. My physiology indicated that I was a > good candidate for a research patient. I told them no thanks. They fully > supported my decision. > I was told to feel free to use over the counter antacids to supplement the > prescription meds as needed. > With regards to the 43.5 times greater cancer risk stat … I asked my doctor > about this. My concern was that this line in the press release was a scare > tactic to help sell the procedure. My doctor agreed that this stat (while true) > is meaningless. It is still a number well below 1% of the population. Keep in > mind that about a third of the population has some kind of reflux and the > number is still very, very small > . > They have done Stretta 25 times now (I would have been #26) and the results so > far look about 80% effective. What they don’t know is how long the benefits > will last after the surgery. When the procedure has been successful, the > patient has been able to dramatically cut back medication or eliminate it > completely. The results they are looking at are less than a year old–less than > a handful are more than six months. > They didn’t give me any written information on the procedure. > Jimmy
