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"The StomaphyX device is an endoluminal fastener and delivery system that consists of an ergonomic, flexible fastener delivery device and sterile [sic] polypropylene fastener implants. All devices are packaged sterile, and are for single patient use."
The StomaphyX device has been cleared by the U.S. Food and Drug Administration for transoral non-invasive tissue approximation (connection) and full-thickness plication (creation of folds) in the Gastrointestinal (GI) tract. It has been used frequently by bariatric surgeons to further reduce the volume of the small stomach pouch created by primary Bariatric procedures such as Roux-en-Y or Gastric Bypass procedures. Many patients experience weight regain due to the small stomach pouch stretching over time. The device is being studied in a prospective, randomized, sham controlled clinical study in order to collect data on this specific post bariatric / revisional use. Early investigator initiated, uncontrolled, clinical studies have demonstrated promising short term weight loss in selected, motivated patients. .
Using a fiberoptic gastroscope (similar to a colonscope for the colon), the esophagus and stomach are easily accessed. The StomaphyX device was designed to go down into the stomach with the fiberoptic endoscope. Once inside the stomach pouch, the StomaphyX tool pleats and staples the stomach to make the pouch smaller.
StomaphyX may benefit:
- Gastric Bypass patients who have regained weight or want to lose more weight
- Duodenal Switch patients who want more restriction
- Sleeve Gastrectomy patients who want more restriction in the remaining stomach
- Those with stomach fistula or leak
- Those with severe dumping syndrome
- Those with low blood sugar (hypoglycemia) from late dumping
The StomaphyX device was patented by EndoGastric Solutions.
Although this procedure has been approved as safe, there is limited evidence to suggest it is effective. One research study indicated that even at one year following the surgery, patients had lost an average of 10 kg (among the 6 participants who followed up). This may suggest that the procedure is not singularly responsible for weight loss in bariatric patients who have regained weight.
- StomaphyX Study at University of Pittsburgh Medical Center
- StomaphyX Clinical Trial at ClinicalTrials.gov
- StomaphyX Clinical Research Study
- StomaphyX at Munroe Regional Medical Center
- StomaphyX at Johns Hopkins Bayview Medical Center
- Stomaphyx Overview
- "First non-invasive bariatric procedure performed in Eastern United States" at OHBlog
- Schweitzer, Michael A. Endoscopic Intraluminal Suture Plication of the Gastric Pouch and Stoma in Postoperative Roux-en-Y Gastric Bypass Patients. Journal of Laparoendoscopic and Advanced Surgical Techniques. August 2004, Volume 14, Issue 4, pages 223-226.
Mikami, D. et al. Natural orifice surgery: initial US experience utilizing the StomaphyX(TM) device to reduce gastric pouches after Roux-en-Y gastric bypass. Surg Endosc. 2009 Jul 25.