BOSTON — Obese patients who had two connected saline–filled balloons temporarily implanted in their stomachs — to induce satiety and jump-start weight loss — shed more pounds than those who underwent a sham procedure. The balloon insertion also appeared to have an acceptable safety profile.
The balloon device was implanted endoscopically and then removed after 6 months. All trial patients received concurrent monthly diet and exercise counseling, Dr Jaime Ponce, medical director of the bariatric-surgery program at Hamilton Medical Center, Dalton, Georgia, told attendees at Obesity Week 2014.
Dr Ponce presented the findings from the REDUCE trial of the ReShape duo integrated dual balloon system (ReShape Medical, San Clemente, California) here during the "top-10-paper" session.
"ReShape is a useful intervention that can be used in patients with a [body mass index] BMI of 30 to 40 who are not ready for surgery or do not qualify for surgery," he said.
The company submitted the results of REDUCE to the US Food and Drug Administration (FDA) in July, and the FDA's decision on the device is expected by the middle of next year.
Balloon Weight-Loss Procedures Common Outside the US
In an interview, Dr Ponce told Medscape Medical News that "outside the United States, [saline-filled balloons have] been used since 1997. Canada, Italy, France, Brazil, and Australia have experience with [this] device."
Some are single balloons, whereas the current device is a dual chamber that more closely resembles the shape of the stomach.
Dr Manoel Galvao Neto (Gastro Obeso Center, São Paulo, Brazil), the assigned study discussant, noted that last year, more than 5000 intragastric balloons were clinically implanted in patients in Brazil.
"We have enough literature to provide a meta-analysis that the balloon is very effective" in filling the gap between clinical treatment and surgery, he said.
For the REDUCE trial, more than 600 patients were screened and 326 were eventually enrolled at eight sites in the United States. The patients had a BMI of 30 to 40 and at least one comorbidity. They had an average age of 44 and an average BMI of 35.4; 95% were female.
There were 139 patients who received the dual saline-filled silicone balloons via endoscopy in an outpatient procedure, while 187 patients underwent a sham endoscopy. Both groups of patients were required to participate in diet and exercise counseling for the length of the study and for 6 months afterward.
The procedures were done quickly; on average, the balloons were inserted in 8 minutes and then removed 6 months later in 14 minutes.
The study aimed to determine whether the difference in excess weight loss between the actual and sham procedures was greater than 7.5%. It also sought to find out whether more than 35% of patients who received the balloons would lose more than 25% of their excess weight.
Both end points were met.
In an intent-to-treat analysis, the difference in weight loss was 13% greater in the group that had the 6-month temporary balloon implant than in the group that received only diet and exercise counseling and a sham procedure (25.1% vs 11.3%, respectively).
Almost half (48.8%) of the patients who had the balloon implant lost more than 25% of their excess weight.
Nausea, vomiting, and abdominal pain, the main adverse events with balloon insertion, tended to occur within the first 30 days and were managed with support and medication as required.
There were no deaths, migration of the balloons, or obstructions.
The balloons had to be removed early in 15% of the patients who did not tolerate them. A single balloon was deflated in 6% of patients without removal of the device.
About a third of patients who received balloon implants had gastric ulcers that were mostly small and superficial; by modifying the endoscopy device tip over the course of the study, this rate was reduced to 10%.
Overall, patients were quite satisfied with the procedure; 64% said they would have it again, if it were offered, and 78% would recommend it to a friend.
FDA Decision Expected Next Year
This was a well-conceived, successful, large, complex trial, Dr Galvao Neto said. Notably, it showed that more than half of the patients lost at least 25% of their excess weight, and 60% maintained this weight loss out to 1 year, he added.
"This is the [level 1] evidence [from a randomized, prospective trial] that we need to get FDA approval for this device," session comoderator Dr Ninh T Nguyen (University of California, Irvine department of surgery), American Society for Metabolic and Bariatric Surgery (ASMBS) president, who was not involved in the study, told Medscape Medical News.
He agrees that if approved, this temporary intragastric balloon device could help patients feel full and, when used in conjunction with diet and exercise, could help initiate weight loss in selected patients.
Asked who would be the best candidates for this procedure, Dr Ponce said: "The patients who will do much better are [those who]…are still trying to lose weight, don't have a BMI [above 40], and are getting ready to be involved in a very well-structured, supervised, weight-loss program."
ReShape Medical sponsored the REDUCE trial. Dr Ponce was a clinical investigator in the REDUCE trial and is a consultant for ReShape Medical, Apollo, and Gore. He is a speaker for Gore and a researcher for USGI Medical. Dr Galvao Neto is a consultant for Apollo, Ethicon, and GI Dynamics. Dr Nguyen has reported he has no relevant financial relationships.
Obesity Week 2014: The American Society for Metabolic and Bariatric Surgery and the Obesity Society Joint Annual Scientific Meeting; November 4, 2014; Boston, MA. Abstract A104.
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Cite this: Intragastric Dual Balloon Induces Weight Loss in US Trial - Medscape - Nov 05, 2014.
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