More Data on Balloon-in-a-Pill Show Almost 15% Weight Loss  

May 23, 2017

PORTO, Portugal — Results from another small trial with a novel intragastric balloon that can be swallowed without the patient requiring endoscopy or anesthesia show that the 42 participants lost an average of 15.6 kg (34 lb), or over 14% of their body weight, over the 16-week duration of the trial.

The patients involved in the study had an average BMI of 38.6 kg/m2 at the start of the study and in this case were put on a ketogenic, very low-calorie diet (700 kcal/day) diet for the last 4 weeks of the trial.

The findings build on preliminary data reported a year and a half ago and recently published (Endoscopy. 2017;49:154-160) with the same Elipse balloon device (Allurion Technologies) showing that it led to 10-kg weight loss in 34 subjects — the addition of the very low-calorie diet in the current trial was designed to enhance the weight loss obtained with the balloon alone.

The results were reported in a poster last week at the European Congress on Obesity (ECO) 2017 by Roberta Ienca, MD, of Sapienza University, Rome, Italy.

Dr Ienca told Medscape Medical News that, so far, more than half of her patients have managed to maintain the weight loss long term.

Elipse Balloon Spontaneously Opens and Is Excreted

Elipse balloon [Source: Allurion Technologies]

The Elipse is a balloon folded into a capsule with a thin catheter attached, which the patient swallows, guided by fluoroscopy. Once the balloon reaches the stomach, it is filled with 550 mL of liquid via the catheter, which is then removed. After 16 weeks, the balloon spontaneously opens, empties, and is excreted through the gastrointestinal tract and passes safely out into the toilet.

In this way, the Elipse differs from other intragastric balloons on the market, which have to be inserted and removed via endoscopy with mild sedation and are usually left in place for 6 months.

These include the ReShape integrated dual balloon system (ReShape Medical) and the Orbera intragastric balloon system (Apollo Endosurgery).

Intragastric balloons are designed to deliver weight loss that is superior to diet and exercise alone but is not on a par with bariatric surgery, said Dr Ienca. However, their use is much safer and the procedure is more cost-effective than surgery, she stressed.

Nevertheless, durability of weight loss is, as ever, key. A large study of more than 3000 people who had received intragastric balloons in Brazil found that 30% of people had regained the weight they lost 6 months after having the balloon removed, and after 3 years, this figure had risen to 70%.

Asked to comment on these latest findings with the Elipse balloon, president of the European Association for the Study of Obesity (EASO), Hermann Toplak, of University of Graz, Austria, said: "Balloons have been used for a long period of time and have failed in the long term."

The Elipse is "an interesting new concept" that appears to represent an easier way to deploy the balloon, he told Medscape Medical News, but he stressed that a large multicenter trial is needed to gain more data.

Safer, Cheaper Option, but Will Weight Stay Off?

Dr Ienca said they saw no serious adverse events with the Elipse balloon in this small trial, which is important because there have been some adverse events of concern with the conventional intragastric balloons — including spontaneous hyperinflation and reports of acute pancreatitis that have necessitated their early removal.

And "because the Elipse balloon does not require endoscopy, surgery, or anesthesia, this may make it suitable for a larger population of obese patients not responding to diet/lifestyle treatment, and also for use by a variety of clinicians — nutritionists, dietitians, and internists — who currently do not have access to or are not qualified to fit endoscopic or surgical weight-loss devices," she said.

"Furthermore, the absence of endoscopy and anesthesia for placement and removal can lead to a significant cost savings," she added. In Italy, the cost of a complete 6-month Elipse program ranges from €2500 to €3500, "depending on the different levels of nutritional follow-up offered."

After the Elipse balloon was secreted, the patients in the current trial were transitioned to a Mediterranean diet for weight maintenance and were kept under constant surveillance for a year.

Dr Ienca told Medscape Medical News that, so far, of the 42 patients, only 30% have regained weight (12% of them regained everything while the remaining ones are still at a lower weight than they were before starting the trial); 55% have maintained their weight loss, while 15% of them have lost more weight adopting a low-calorie diet.

In theory, use of the Elipse balloon could be repeated, she said, although this was not tested in the current study.

The Elipse was approved in the European Union in 2015 and is currently in use in several European countries, including France, Italy, Spain, Belgium, Greece, and the United Kingdom, and it is available in some Middle Eastern countries such as Saudi Arabia, Kuwait, and Qatar.

Dr Ienca has no relevant financial relationships.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1 . For more diabetes and endocrinology news, follow us on Twitter and on Facebook .

European Congress on Obesity 2017; May 17-20, 2017. Porto, Portugal. Poster T3P5.

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