LOS ANGELES, CA — An experimental gastric balloon (Ellipse, Allurion Technologies) that is swallowed in a doctor's office, stays in the stomach for 4 months, and is then excreted, appears to be a safe, effective way to help obese people temporarily eat smaller portions and lose weight, according to a preliminary study.
Unlike other gastric balloons, the Ellipse does not require endoscopy or sedation to insert or remove it, Ram Chuttani, MD, director, interventional gastroenterology and endoscopy, Beth Israel Deaconess Medical Center, Boston, Massachusetts, stressed, presenting the findings recently at Obesity Week 2015.
This is a "feasible, safe, effective [weight-loss device] that improves both metabolic and quality-of-life parameters and eliminates the requirement for endoscopy and anesthesia," Dr Chuttani summarized.
In the current study, 34 patients in Greece and the Czech Republic with a mean body mass index (BMI) of 34.4 kg/m2 lost an average of 10 kg after 4 months, a similar weight loss to that observed with traditional gastric balloons, he said. Importantly, there were no serious adverse events or device effects; the side effects were mild or moderate and included nausea, vomiting, and abdominal cramps, which have also been reported with traditional gastric-balloon therapy.
Asked to comment, session cochair Dan E Azagury, MD, a bariatric surgeon and assistant professor of surgery at Stanford University, California, told Medscape Medical News that the use of gastric balloons for weight loss in obese patients is increasing in the United States, and this devices offers "a very different alternative."
The biggest advantage is probably a lower cost, due to the way the device is deployed and removed, he noted.
However "it's a temporary measure for a permanent problem," according to Dr Azagury. "I think there's a role for the balloon in the treatment of our patients, but…it's [different] from what we see in bariatric surgery [such as] gastric bypass."
Moreover, these are very early data from outside the United States, and "it's up in the air what the [device-approval] pathway would be through the Food and Drug Administration [FDA]," he added. "I think we're still looking at years before this" becomes available for use in the United States.
Two "Traditional" Gastric-Balloon Devices Approved
In the past few months, the FDA has approved the use of two "traditional" gastric balloons for weight loss in obese adults with a BMI of 30 to 40 kg/m2 who have been unable to lose weight through diet and exercise.
In addition, the FDA has okayed three other devices to treat morbid obesity: the Allergan LAP-Band , the Ethicon Endo-Surgery Realize Adjustable Gastric Band, and the Maestro Rechargeable System (a rechargeable vagal-nerve–blocking device).
Into this mix of devices, this "procedureless" gastric balloon is designed to offer a novel alternative. The device was shown to be safe and effective in a proof-of-concept study in eight patients (Obes Surg. 2015; DOI: 10.1007/s11695-015-1783-7).
The procedure is done in a doctor's office, Dr Chuttani explained. The patient swallows the rolled-up gastric balloon (the size of a quarter) along with a thin capillary tube. When the balloon reaches the stomach, 550 mL of filling solution is introduced into the balloon via the tube, which is then removed.
In the next few months while the device remains in the stomach, the patient is encouraged to lead a healthier lifestyle with good portion control. Patients feel full after eating less.
At 4 months, the device is designed to open, so that the filling solution empties and the balloon is excreted via the digestive tract.
The current study enrolled 23 women and 11 men with a mean age of 42 and BMIs ranging from 27 to 40.
In one patient, the device did not deploy properly; two patients withdrew due to adverse symptoms (at day 1 and at 8 weeks); and six patients have not yet completed the study.
In the 25 patients with complete results, mean BMI dropped from 34.8 to 31.4; mean waist circumference dropped by 8 cm; and quality-of-life scores improved significantly. Most patients said they would recommend this procedure to a friend and they would repeat the procedure if they regained the weight.
In total, the researchers plan to enroll 50 patients in this ongoing study.
The research was funded by Allurion Technologies. Chuttani is a senior medical advisor at Allurion and has shares in the company.
Obesity Week 2015; Los Angeles, California. Presented November 5, 2015.
Editor's note: This article originally stated the balloon stays in the stomach for 4 weeks, not months. It has been corrected.
Medscape Medical News © 2015 WebMD, LLC
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