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Obalon balloon

Obalon balloon reduces BMI in six-month study

The Obalon group experienced improvements in systolic blood pressure, fasting glucose, LDL cholesterol and triglycerides

Patients who had a BMI30-40 lost nearly 7 percent of their weight, on average, after using the Obalon 6-Month Balloon System (Obalon Therapeutics), according to research presented at Digestive Disease Week (DDW) 2016. They also significantly improved in other health indicators, such as blood pressure and cholesterol levels data from the study, ‘The Obalon Swallowable 6-Month Balloon System is more effective than moderate intensity lifestyle therapy alone: results from a six-month randomised sham controlled trial’, showed.

"Our research shows that the studied balloon system can help patients lose almost twice as much weight compared with lifestyle changes alone," said Dr Shelby Sullivan, the study's lead researcher and director of bariatric endoscopy at Washington University School of Medicine in St Louis, MO. "This is important because weight loss is very difficult and a significant number of people are not successful in achieving their weight loss goals with diet changes and exercise."

Obalon balloon

The Obalon balloon is designed to jump-start weight loss by partially filling the stomach and helping to induce a feeling of fullness to help people eat less. The patient swallows a capsule containing a balloon, which is attached to a micro-catheter. Once the capsule arrives in the stomach, the outer layer dissolves. The balloon is then simply inflated to the size of an apple, through the micro-catheter, without the need for an endoscopy or sedation.

Once inflated, Obalon sits comfortably at the top of the stomach sending messages to the brain to decrease the feeling of hunger, which encourages reduced food consumption and calorie intake. Following a healthy eating plan in conjunction with Obalon ensures enhanced weight loss. Unlike other balloon treatments, there is no need to eliminate certain foods; you simply eat less due to a reduced appetite, the company claims.

Researchers at 15 study sites in the US randomly assigned 387 patients to either the treatment group or a control group. Individuals in the treatment group were asked to swallow three capsules (one every three weeks) that each contained an Obalon balloon. Immediately after participants swallowed the capsules, the balloons each were filled with 250 cubic cms of a nitrogen-based gas via a small catheter attached to the capsule.

For the control group, researchers asked these individuals to swallow three sugar-filled capsules (also once every three weeks). The researchers then mimicked the process of filling the sugar capsule with gas so that participants in this group did not know that they were in the control arm of the study.

Researchers found that within the Obalon balloon treatment group, the average loss of total body weight was 6.81 percent, while the control group's average weight loss was 3.59 percent.

Sullivan and her team also found that 64.3 percent of individuals who received the Obalon balloon achieved at least a 5 percent total body weight loss, compared to only 32 percent of the control group. Individuals in the Obalon balloon treatment group experienced improvements in their systolic blood pressure, fasting glucose, LDL cholesterol and triglycerides.

"While patients in our study who used this balloon system had a nearly 7 percent total body weight loss, I believe that, once this system is used in the 'real world,' patients will experience more than that," added Sullivan. "This projection is based on the fact that we've seen other weight-loss interventions help people lose more weight than what occurred in clinical trials for those treatments."

The Obalon balloon is not approved in the US and is available for investigational use only. The Obalon balloon is approved for sale in the European Union, Mexico and the Middle East.

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