Allegheny Health Network Among 15 Centers Nationwide Launching Clinical Trial of Non-Surgical Weight Loss Balloon
Tuesday, April 21, 2015
Allegheny Health Network today announced its participation in the first U.S. clinical trial evaluating the effectiveness of a non-surgical alternative, the Obalon Balloon, in helping people lose weight.
A team led by George M. Eid, MD, FACS, FASMBS, System Division Chief, Minimally Invasive Surgery, and System Director, Bariatric and Metabolic Institute, will examine whether the Obalon Balloon, which is placed when the patient swallows an inflatable capsule, can help people who have struggled to lose weight with diet and exercise.
“Many patients need help losing weight but are not interested in, or don’t qualify for, bariatric surgery,” Dr. Eid said. “The Obalon Balloon could offer an alternative that is discreet, non-surgical and reversible, leading to progressive weight loss over a six-month period.”
With the progressive Obalon approach, a total of three balloons are placed over several weeks. The patient swallows the capsule containing the balloon, then it is inflated with gas. The balloon is designed to occupy space in the stomach so that the patient feels fuller and eats less. After six months, the balloons are removed in an outpatient procedure, using a flexible tube/camera that is inserted into the mouth.
Participants in the study will be randomized into two groups; one will receive the Obalon Balloon, the other, a sham device. All patients will receive diet and exercise counseling. After six months, the balloons will be removed and patients will be told if they received the balloon or a sham.
Patients who received the balloon will then begin a second six-month weight loss session without the balloons, continuing to visit their doctor’s office for diet and exercise counseling. Those who did not receive the balloon but still qualify for the study, will have the option to receive the Obalon Balloon at no cost.
The Obalon Balloon is not currently commercially available in the U.S., but is approved in some European countries.
To qualify, patients must be 22 to 64 years old, have a Body Mass Index between 30 and 40, not have had or be considering bariatric surgery, and able to attend regular appointments over a one-year period. For more information, call 1-855-878-8390.
About the Allegheny Health Network:
Allegheny Health Network, part of Highmark Health, is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; a research institute; Health + Wellness Pavilions; an employed physician organization, home and community based health services and a group purchasing organization. The Network employs approximately 17,500 people and has more than 2,100 physicians on its medical staff. The Network also serves as a clinical campus for Temple University School of Medicine, Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.