The intragastric dual balloon is safe, easy to use, and boosts weight loss, according to results of a small study recently published in Surgery for Obesity and Related Diseases.
Intragastric balloons are designed to occupy space within the stomach to help patients feel full and satisfied with less food. The device can be left in the stomach for up to six months. Weight loss success depends on patients adopting lifestyle changes, including a healthier diet and increased physical activity.
Clinical trials are ongoing to win FDA approval for use in the United States. As for now, the intragastric balloon is available in Canada, Europe, South America, and other parts of the world.
Methods
The study, A Prospective, Randomized, Multicenter Study To Evaluate The Safety And Efficacy Of The Intragastric Dual-Balloon In Obesity, was authored by Jaime Ponce, MD, Brian B. Quebbemann, MD, Emma J. Patterson, MD. The aim was to evaluate the safety and efficacy of the intragastric dual balloon in obese patients.
The study included 30 patients (26 females and 4 males aged 26-59 years) who were randomized to the treatment group (21 patients) or a control group (9 patients) among three treatment sites. The patients in the treatment group underwent endoscopic placement of the dual balloon. Both groups received similar diet and exercise counseling. The device was removed after 24 weeks.
Results
At 24 weeks, the mean excess weight loss was:
- 31.8 +/- 21.3% in the treatment group
- 18.3 +/- 20.9% in the conrol group
At 48 weeks (24 weeks after device removal), the treatment group maintained 64% of their weight loss.
In the treatment group, four patients were readmitted for severe nausea; at time of removal, one patient had asymptomatic gastritis and one patient experienced transient hypoxia. There were no deaths, unanticipated adverse effects, early removals, balloon deflations or migrations.
The authors concluded that the “dual balloon proved easy to use, associated with a trend towards greater weight loss than a control group, and demonstrated a good safety profile.”
About the ReShape Duo
The ReShape Duo Weight Loss Balloon System is designed to assist weight loss efforts in patients who have been unsuccessful in losing weight through diet alone and who do not qualify for or do not want to undergo bariatric surgery. To achieve successful weight loss, patients will need to make lifestyle changes in diet and physical activity.
Key benefits of the ReShape Duo:
- Ease of use – placed and removed during a quick, outpatient, endoscopic procedure
- Tolerability – the dual balloon conforms better to curvature of stomach for improved patient comfort and fewer early removals
- Weight loss – fills more space than a single balloon for increased satiety; studies have shown patients lose, on overage, 1/3 of their excess weight in 6 months
- Safety – the dual balloon design helps mitigate risk of migration and/or obstruction
Even though studies have shown a good safety profile, potential complications include: nausea and vomiting, ulcers and infections, obstruction and stomach perforation, and modest weight loss.
The ReShape Duo Weight Loss Balloon System has been available in Canada since 2006 and Europe since 2007. It is currently being evaluated as part of an FDA study in the United States.
For those who are interested, more information about the ReShape Duo and the REDUCE clinical trial can be found at reducetrial.com/trial/. Patients should also consult with a bariatric surgeon to see if this procedure is reasonable in their situation.
Source: “A Prospective, Randomized, Multicenter Study To Evaluate The Safety And Efficacy Of The Intragastric Dual-Balloon In Obesity,” Jaime Ponce, MD, Brian B. Quebbemann, MD, Emma J. Patterson, MD, Surgery for Obesity and Related Diseases, published online August 2012.
