StomaphyX

StomaphyX is an endoscopic suturing system designed to treat patients who have had previous Roux-en-Y gastric bypass surgery. Following this surgery, the stomach pouch and stomach outlet (stoma) becomes enlarged in some patients. The StomaphyX device can be used to restrict the size of the stoma without exposing the patient to further surgical risk.<ref name="Woods2010">Woods KE, Abu Dayyeh BK, Thompson CC. Endoscopic post-bypass revisions. Techniques in Gastrointestinal Endoscopy. 2010;12(3):160–166. doi:10.1016/j.tgie.2010.10.002

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Although initial post-procedure weight loss is evident in some trials, there is doubt as to whether such results are sustained over the long term.<ref name="Goyal2013">Goyal V, Holover S, Garber S. Gastric pouch reduction using StomaphyX in post Roux-en-Y gastric bypass patients does not result in sustained weight loss: a retrospective analysis. Surgical Endoscopy. 2013;27(9):3417–3420. doi:10.1007/s00464-013-2905-8

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The StomaphyX device was patented by EndoGastric Solutions.

Medical uses

StomaphyX has been used by bariatric surgeons to further reduce the volume of the small stomach pouch created by gastric bypass procedures. Many patients experience weight regain due to the small stomach pouch stretching over time. The use of an endoscopic procedure to correct this problem is appealing because, if successful, it could reduce risk to the patient that can be associated with more invasive surgical procedures.<ref name="Woods2010" />

Technique

The esophagus and stomach are accessed using a fiberoptic gastroscope (similar to a colonscope for the colon). The StomaphyX device is designed to go down into the stomach with the gastroscope. Once inside the stomach pouch, pleats are formed using polypropylene fasteners to make the pouch smaller.<ref name="Goyal2013" />

Efficacy

Early investigator-initiated uncontrolled clinical studies with small patient groups have demonstrated short-term weight loss in some patients. For example, a study of 27 patients found most achieved weight loss during the first six months after the procedure.<ref>Ong'uti SK, Ortega G, Onwugbufor MT, Ivey GD, Fullum TM, Tran DD. Effective weight loss management with endoscopic gastric plication using StomaphyX device: is it achievable? Surgery for Obesity and Related Diseases. 2013;9(1):113–117. doi:10.1016/j.soard.2011.08.025

. .</ref> However, a randomized sham-controlled study was terminated in 2011 because the device failed to achieve the study's 15% target reduction in body mass index (BMI) in 50% of patients treated with it.<ref>Eid GM, McCloskey CA, Eagleton JK, Lee LB, Courcoulas AP. StomaphyX vs a Sham Procedure for Revisional Surgery to Reduce Regained Weight in Roux-en-Y Gastric Bypass Patients. JAMA Surgery. 2014;149(4):372. doi:10.1001/jamasurg.2013.4051

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