Holyoke Medical Center Weight Management Program is screening candidates for Allurion Technologies U.S. study of its Elipse Gastric Balloon.
Natick-based Allurion Technologies has developed a swallowable gastric balloon and is seeking patients for a clinical study of the device.
Holyoke Medical Center Weight Management Program is screening candidates in this area of the country to try the device, which is marketed under the trademark "Elipse."
Those interested in the study must have a Body Mass Index of 30 or over, which is consider in the obesity range.
Allurion hopes the device, which is temporarily placed in the stomach to take up space and expelled naturally after four months, will be approved by the Food and Drug Administration for use in the United States. The system, which differs from other gastric balloon devices as it does not involve endoscopy surgery for placement or removal, and is not permanent as some forms of bariatric surgery are for weight loss, was approved for marketing in Europe in 2015.
A board certified bariatric surgeon who founded HMC's weight management program in 2016, Dr. Yannis Raftopoulos said his program is one of 12 sites involved in the U.S. study, what he said is a randomized controlled one, and the only site in the Northeast.
Raftopoulos has already placed the device in patients in Greece, and participated in a European study for it funded by Allurion.
He was one of two lead investigators in that 2015 study, involving some 34 patients in the Czech Republic and Greece, and whose results he presented at a number of conferences both in this country and abroad.
Raftopoulos said that study, which was not randomized controlled, showed the device to be "safe and effective" and resulted in "no serious complications."
"We only observed usual and expected side effects after placement such as nausea, occasional vomiting, reflux and cramps which usually resolved in three to four days," Raftopoulos said.
He said the device's novelty is that it "requires no anesthesia, sedation, endoscopy or surgery."
"The balloon is packaged into a small capsule and is swallowed with some water under Xray. It is filled with water (through a thin delivery catheter that is then removed). The placement takes 10 to 14 minutes. It works by occupying a space in the stomach resulting in less appetite and increased satiety," Raftopoulos said.
"The balloon has a release valve with is programmed to open at 16 weeks allowing the balloon to empty from the water and pass in the stool. If required it can be punctured endoscopically and be removed without difficulty. I had to remove it prematurely and electively in one patient who was not able to take enough fluids and nutrition three weeks after placement."
Raftopoulos described what the balloon is made from as a "patented multi-layer material strong enough not to dissolve from the gastric acidity and flexible enough to be able to be packaged within a small capsule. It's 85 percent thinner than existing balloons," Raftopoulos said.
The FDA approved a system from Obalon Theurapeutics, which uses a gas-filled balloon and does not require endoscopy for placement in September 2016.
ReShape Medical's Integrated Dual Balloon System and ORBERA Intragastric Balloon System, manufactured by Apollo Endo Surgery, received FDA approval, in 2015, for their gastric balloon systems that require endoscopy for placement and removal. Both were subjects of recent FDA alerts.
Raftopoulos said there is an "extensive list of inclusion and exclusion criteria."
"A patient must be between 22 to 65 years old and have a Body Mass Index of 30-40," he said.
"They will be monitored by me and the (weight management) program's nutritionists once a month for a year. They must be committed to follow."
He sees this type of ingestible gastric balloon system as "beneficial for patients who are not qualifying for bariatric surgery, patients who do not want surgery, patients who need to lose substantial weight before surgery" and the fact this type of temporary surgery "can be repeated."
"I have three patients in Greece who repeated the treatment and one of them reached a normal weight already," Raftopoulos said.
Criticisms that such therapy is a temporary fix is why, Raftopoulos said, that he constructs it in Greece "to include an intensive followup for 12 months with me and in a form of a group with a nutritionist and psychologist."
"In addition each patient is provided with a special scale/body composition analyzer connected through an app with their smartphone and can send me measurements weekly. This remote followup has been very successful," Raftopoulos said.
"So far I have patients who are over a year out and all have maintained all weight lost. Don't forget also that weight gain can occur with surgery also if there is no proper and structured follow up."
Allurion also conducted a small trial led by Roberta Ienca, a researcher in experimental medicine at Sapienza University in Rome, that involved 42 patients -- 29 men and 13 women.
The findings were presented at the 217 European Congress on Obesity in Porto, Portugal.
The system has received press in some of Europe's larger media outlets.
Anyone interested in participating in Allurion's U.S. study and seeing if they may qualify, needs to visit balloontrial.com.