Hamilton Medical Center is one of three sites in the United States involved in the initial phase of a clinical trial for an experimental weight-loss treatment that doesn't require surgery.
Fifteen patients of the hospital already have been implanted with balloons that take up space in their stomach to limit the capacity for food, said Dr. Jaime Ponce, who is leading the study at Hamilton and is medical director of the bariatric program at Hamilton Medical Center in Dalton, Ga., and Memorial Hospital.
Although initially many of the patients experienced nausea as their stomachs adjusted to having two balloons in them, Dr. Ponce said he was "amazed how they evolved to tolerate the balloon."
For patients with a body-mass index between 30 and 40, who may not be big enough to qualify for bariatric surgery, the 15-minute procedure could be a way to kick-start a stalled diet and exercise program, making long-term weight loss easier, he said.
"It's like everything is working against them when they're overweight and it's working for them when they're at a healthy weight," he said.
For those too big to qualify for standard bariatric surgery, the technique also could help them lose weight, although the clinical trial is not testing that use, said Mark Ashby, vice president of research and development at ReShape Medical, the California-based company that created the device.
Mr. Ashby said the device is different from most balloon-based weight-loss devices because it uses two smaller balloons, linked together but with separate chambers, instead of one large balloon.
That set-up provides a back-up in case one balloon pops, preventing the materials from moving down the digestive tract while also providing more comfort for the patient, he said. Two small balloons can inflate into a large volume throughout the stomach in a less-intrusive way, reducing stomach capacity even more than a single balloon could, he said.
Dr. Jack Rutledge, a bariatric surgeon with University Surgical Associates who is not involved in the study, said the balloon technique could be beneficial in some situations. But like lap-band surgery, patients who undergo this treatment could still feel hunger; they'll just be unable to eat and satiate that hunger, he said.
Bariatric surgery has the benefit of actually resulting in hormonal changes that reduce the production of chemicals in the body that stimulate hunger, and the effects are permanent, he said.
Unless balloon patients also focus strongly on lifestyle changes, they might quickly put back on the weight after the balloon is removed, he said.
"It could be used as a kick-start (to a diet), but I think the take-home message is there's no expectation this will be a long-term solution," he said.
In the local study, Dr. Ponce will follow patients for six months after the balloons are removed to track their results. The next phase of the trial will likely include about 300 patients at 30 sites nationwide, Mr. Ashby said.
After the trials are complete, the U.S. Food and Drug Administration will consider approving the technique.