Background

With obesity rates rising, patients and physicians have an increasing interest in non-surgical weight-loss options. Endoscopic gastric balloons have shown success to date and new devices are continually developing. Of current interest is the FDA-approved Obalon system, comprised of 3 nitrogen filled balloons swallowed in a staged fashion and removed after 6 months. We aimed to evaluate the safety profile and success of this balloon system.

Methods

Sixty-three patients from a multicenter bariatric practice were studied prospectively between January 2017 and April 2018. Patient data collected included age, gender, starting weight, BMI, treatment duration and adverse events. Statistical analysis was performed for excess weight loss(EWL), total body weight-loss(TBWL), and BMI change.

Results

The cohort was predominantly female with an average age of 42. Average starting weight was 225lbs and BMI 36.1. Average weight loss was 21lbs, TBWL 9.3%, and EWL 34.2%. BMI decreased by 3.2. Over 65% of patients achieved >5 % TBWL. There was a significant difference between patients who completed the 150-day course(82.5%) versus patients who had early balloon retrieval in terms of weight reduction(p=0.022), TBWL(p =0.019), EWL(p =0.015), and BMI(p=0.015). No major adverse events occurred. Minor complications occurred in 22.2 % of patients: gagging(9.5%), gastric ulcers(3.2%), nausea(3.2%), abdominal pain(3.2%), vomiting(1.6%), dyspepsia(1.6%), and device intolerance(1.6%).

Conclusions

From our experience the Obalon balloon is a safe and effective non-surgical weight loss option. There were no serious complications and the majority of patients experienced weight reductions. Future studies will focus on determining optimal treatment duration.