Have you had an invasive weight loss surgery such as Gastric Bypass or Roux-En-Y to help treat your obesity? If so, have you been one of the many who have developed common complications from these procedures? If the answer is yes, then you may have heard of this procedure.
StomaphyX is a single-use endoscopic device that FDA cleared in 2009 as a tissue approximation device, used to create tissue folds in the gastrointestinal tract. After gastric bypass, it was studied as a way to achieve weight loss.
StomaphyX is performed under general anesthesia, the procedure takes approximately 30 minutes and most patients can return to their daily activities the next day or within a few days, on a soft liquid diet for roughly two weeks. StomaphyX is inserted through the mouth and is gently advanced into the stomach under direct visualization of the endoscopic camera. Once inside the stomach, the stomach wall is suctioned into the device’s tissue port creating a large tissue fold, and non-absorbable fasteners are then placed across the fold to hold the tissue in place.
StomaphyX does not involve skin incisions, but it is not risk-free. In a sham-controlled trial, one adverse event caused by the procedure required laparoscopic surgery to repair. In that randomized trial, enrollment closed early because StomaphyX failed its efficacy target: 22.2% reached the target at 12 months, compared with 3.4% after the sham procedure.
