HMC Weight Management Program Participates in Clinical Study
HOLYOKE — The Holyoke Medical Center (HMC) Weight Management Program is currently screening patients to participate in a clinical study of the Elipse Balloon for U.S. Food and Drug Administration (FDA) approval. The Elipse Balloon is manufactured by Natick-based Allurion Technologies.
Holyoke Medical Center’s Weight Management Program is one of 12 locations selected nationally to be involved in the FDA trial of the Elipse Balloon. The hospital was selected based on the experience of Medical Director Dr. Yannis Raftopoulos, who is the only physician in the U.S. with hands-on experience with the Elipse Balloon. He was one of the two lead investigators of a European trial for the Elipse Balloon in 2015 which allowed the device to obtain the CE mark and become commercially available in Europe and subsequently the Middle East. The results of this trial have been published in peer-reviewed medical journals and presented at national and international meetings for the treatment of obesity. Raftopoulos has been offering the Elipse Balloon to patients in Greece since it was approved for use in 2016.
The Elipse Balloon is an investigational device for weight loss that does not involve surgery or incisions. The product is designed to occupy space in the stomach to help patients feel fuller, eat smaller portions, and lose weight. Unlike other weight-loss options, the Elipse Balloon requires no surgery, no endoscopy, and no anesthesia.
The balloon comes in a capsule attached to a thin flexible tube. The patients simply swallow the capsule with water while the doctor takes an X-ray to make sure the capsule is in the stomach. Once in place, the balloon is filled with distilled water, and the tube is removed, completing the process, which takes about 15 minutes.
The Elipse Balloon remains in the stomach for about four months, serving as built-in portion control while the patient learns to live a healthier lifestyle with the support of nutritionists, doctors, and nurses. After that time, the balloon will empty on its own and pass naturally.
“I am excited to be a part of the clinical study for FDA approval after seeing the benefit of this product in Europe,” said Raftopoulos. “Once approved, this innovative device will offer a new approach to non-surgical weight loss.”
The HMC Weight Management Program opened in February 2016 and has treated over 1,100 patients. Patients who participate in its surgical weight-loss program lose an average of 37% of their initial total body weight in one year, and half of them achieve a completely normal weight. In addition, nine out of 10 patients who participate in the medical weight-loss program lose weight, with best responders losing more than 100 pounds. The program is accredited as a comprehensive center under the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, a joint program of the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery, and has received two best-practice awards.
“We are extremely proud of the Weight Management Program and Dr. Raftopoulos for the dedication to researching new and innovative ways to combat obesity,” said Spiros Hatiras, president and CEO of Holyoke Medical Center and Valley Health Systems. “Having our local community hospital selected to participate in this groundbreaking, national study validates the expertise and superior care available at Holyoke Medical Center.”
For more information on the clinical study, visit balloontrial.com.