95:– the region of the stomach just below the LES. The energy heats the tissue, ultimately causing it to swell and stiffen; the way this works was not understood as of 2015, but it was thought that perhaps the heat causes local inflammation, collagen deposition and muscular thickening of the LES and that it may
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ASGE Standards of
Practice, Committee; Muthusamy, VR; Lightdale, JR; Acosta, RD; Chandrasekhara, V; Chathadi, KV; Eloubeidi, MA; Fanelli, RD; Fonkalsrud, L; Faulx, AL; Khashab, MA; Saltzman, JR; Shaukat, A; Wang, A; Cash, B; DeWitt, JM (June 2015). "The role of endoscopy in the management of GERD".
149:
One was a systematic review and meta-analysis of clinical trials conducted with
Stretta, done in response to the 2013 SAGES review (which did not include meta-analysis). This review found that quality of studies that had been conducted was generally poor, and that compared with sham therapy (used a
130:
The device for carrying out the procedure was originally developed by a company called Curon which obtained FDA approval for the device in 2000 but then went bankrupt in 2006; the device was brought back to market by Mederi
Therapeutics in 2010. The procedure costs between $ 3,000 and $ 4,000 as of
164:
A more recent study published in 2020 evaluated 25 patients post
Stretta Procedure and the results concluded significant improvement in reflux symptoms and quality of life, lowering Heartburn Score (DeMeester score) from 3.7 in women and 4.0 in men to 1.6±1 (p = 0.05) in women and 1.68±1.19 (p =
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The other 2015 review was a narrative literature review was more tentative, noting the long safety record but only willing to state that the procedure "may be effective in reducing symptom burden and quality of life scores up to 8 years post-intervention. However, there does not appear to be any
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placebo for medical device clinical trials), the procedure did not change time spent at a pH less than 4, did not increase lower esophageal sphincter pressure (LESP), did not allow people to stop treatment with proton-pump inhibitors, and did not improve health-related quality of life.
600:
Perry, KA; Banerjee, A; Melvin, WS (August 2012). "Radiofrequency energy delivery to the lower esophageal sphincter reduces esophageal acid exposure and improves GERD symptoms: a systematic review and meta-analysis".
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In 2015 three reviews were published discussing the relative safety and effectiveness of the procedure compared with other endoscopic procedures delivered through the mouth, drug treatment (generally
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251:
Lipka, S; Kumar, A; Richter, JE (June 2015). "No evidence for efficacy of radiofrequency ablation for treatment of gastroesophageal reflux disease: a systematic review and meta-analysis".
157:, noted its long history of use, and found the procedure safe and effective, and noted that the procedure complemented drug treatment and fundoplication, providing a useful option.
119:, which involves making incisions in the torso and wrapping part of the stomach around the base of the esophagus, and which is considered the gold standard for efficacy. In 2015 an
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An
American Society of Gastrointestinal Endoscopy (ASGE) statement in June 2015 state that endoscopic antireflux therapy is a potential treatment based on the 2012 review.
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Auyang ED; Carter P; Rauth T; et al. (2013). "SAGES clinical spotlight review: endoluminal treatments for gastroesophageal reflux disease (GERD)".
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sustained improvement in objective outcomes and there is no evidence that
Stretta results in improved outcomes as compared to surgical intervention.
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A 2012 systematic review and meta-analysis upon which the 2013 SAGES review had relied, had found that it improves GERD symptoms.
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guideline noted that the quality of evidence was low for
Stretta and the other available endoscopic treatment for GERD (
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528:"Long-term results of the stretta procedure in patients with gastroesophageal reflux: A single-center experience"
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Lo WK, Mashimo H (Oct 2015). "Critical
Assessment of Endoscopic Techniques for Gastroesophageal Reflux Disease".
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ASGE Standards of
Practice Committee (June 2015). "The role of endoscopy in the management of GERD".
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recommending against its use in 2013, and in the same year the
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Surgical Laparoscopy, Endoscopy & Percutaneous Techniques
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Neto RL, Herbella FM, Schlottmann F, Patti MG (May 2019).
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189:Hopkins J; et al. (Aug 2015).
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669:Digestive system procedures
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379:Gastrointestinal Endoscopy
89:lower esophageal sphincter
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117:Nissen fundoplication
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75:(GERD) that delivers
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309:10.1038/ajg.2012.444
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