Most physicians who treat obesity would agree that gastric bypass surgery is often an effective solution. But the heartbreaking truth of the procedure is that as many as 44% of gastric bypass patients experience weight regain within a few years of the operation.

Fortunately there is an incisionless procedure, Restorative Obesity Surgery Endolumenally, nicknamed the ROSE procedure, that is intended to reduce the size of the patient's stomach pouch and stoma to about the original post-operation proportions to help them back onto the weight loss path.

Bluegrass Bariatric Surgical Associates (Lexington, Kentucky) said it has enrolled the final patient in a 116-patient, nine-site registry designed to evaluate the results of the ROSE procedure. Bluegrass bariatrics surgeons G. Derek Weiss, MD, and John Oldham, Jr., MD, are participants in the registry. All of the patients in the registry will be followed for two years.

"Like anybody, I was a little skeptical at first because I know the competitor's product, the word was they weren't holding up," Weiss told Medical Device Daily. But after performing the ROSE procedure on 26 of the registry patients, he is convinced that "this is the real deal."

Weiss said he saw a patient just last week who lost 42 pounds in three months following the ROSE procedure and that the patients he had performed the procedure on tell him that the feeling of restriction they felt following their original gastric bypass surgery.

To perform ROSE, surgeons use a small, flexible endoscope and a new EndoSurgical Operating System (EOS) developed by USGI Medical (San Clemente, California).

The EOS is inserted through the mouth and into the stomach pouch. The EOS tools are then used to grasp tissue and deploy suture anchors to create multiple, circumferential tissue folds around the stoma, reducing the diameter of the stoma. If needed, additional anchors are then placed in the stomach pouch to reduce its volume capacity. No cuts are made into the patient's skin during the procedure, the company notes.

"Traditionally, patients who regained weight after gastric bypass had few options to reverse that weight gain because their original surgery make an 'open' revision far too dangerous," Weiss said. "The ROSE procedure helps overcome the past safety issues of open surgery with very short recovery times and minimal side effects. Our first patient lost 25 pounds in the first month following ROSE. We look forward to following all of our patients to determine the long term results of the procedure which we believe has the potential to dramatically impact bariatric surgery."

Because traditional gastric bypass revision surgery is so risky, a lot of insurance companies won't cover it, Weiss said. He said there is "really nothing to lose doing this," because the ROSE procedure is a low-risk solution and, from what he has seen so far, it works.

"I'm seeing real results, I think eventually anything good will surface to the top," Weiss said.

All the patients who participated in the study had lost at least half of their excess weight following an initially successful Roux-en-Y gastric bypass operation – the most common type of the surgery – but then subsequently began to regain weight. Researchers will assess the success, duration and safety of the procedure, how much weight the patients lose and changes in their co-morbidities, such as diabetes.

Endoscopic evaluations will be performed at three months and a year after the ROSE procedure to determine the size of the patient's pouch and stoma, as well as how well the anchored tissue folds have held and how their tissue has responded to the anchors.

According to USGI, more than 200,000 people in the U.S. underwent bariatric surgery in 2007, and it is estimated that more than 125,000 patients today are candidates for an incisionless revision procedure.

Weiss said that gastric bypass surgery is something that every surgeon does differently. The object, of course, is to create a small pouch from the upper stomach accompanied by bypass of the remaining stomach so as to restrict the amount of food that can be eaten. But there is nothing really set about how big the surgeon makes that small pouch, Weiss said. As it turns out, he said, if the surgeon doesn't do what is called a micropouch and exclude the stretchy part of the stomach, there is a high likelihood that it will stretch out and the patient could experience significant weight regain.

"What we've learned in doing this study is that the majority of the patients who are gaining weight don't have small pouches ... there are a lot that have these larger pouches," Weiss said.

He expects the ROSE procedure to play a "huge role" in bariatric surgery that hopefully will someday be covered by insurance.

John Cox, VP of sales & marketing for USGI, told MDD that the EOS device was designed to offer the three fundamental things a physician would expect from such a tool – access, tools and instruments similar to endoscopic tool, and wound closure – all based on a platform that uses the patient's natural orifices.

The EOS device includes the TransPort multi-lumen operating platform, the g-Prox tissue grasper and approximation device, g-Cath tissue anchors and a variety of endosurgical tissue graspers. Its features include: access and visualization of the operation site; multiple, robust tools and instruments for two-handed operation; and fast, durable suturing for tissue apposition and wound closure.

While USGI appears to be the frontrunner in the space so far, Cox said the company expects the market space to get crowded as more companies begin working on this type of solution.

"We're probably just the first ones with good data and the first ones with great applications and technology," Cox said.

Because of how risky the traditional gastric bypass revision surgery is, not many patients are eager to have it done. This incisionless procedure, however, could offer a real alternative for those patients.

"When they find out you can do it all through the mouth ... patients jump at the chance, and surgeons do too," Cox said.

He pointed out something he says most people don't realize: all of the visible scars and nearly all of the pain a patient feels during recovery from a surgery comes from the access part of the operation, not the procedure itself.