Clinical Trials

The purpose of this study is to determine whether the ORBERA Intragastric Balloon is a safe and effective means for weight loss and improved metabolic disease in patients with cirrhosis requiring liver transplantation.

A prospective, multicenter, open-label, post-approval study of the safety and effectiveness of ORBERA™ as an adjunct to weight reduction for obese adults (22 years of age and older) with a Body Mass Index (BMI) of ≥ 30 kg/m2 and BMI ≤ 40 kg/m2

The purpose of this study is to evaluate the safety and effectiveness of the Spatz3 in subjects with a BMI ≥ 30 and < 40 who have failed to achieve and maintain weight-loss with a weight control program.

The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. ORBERA™ is a special balloon approved by the FDA for overweight adults, and we would like to try using it for overweight teenagers.

The purpose of this study is to demonstrate that the safety of the device in the postmarket setting is comparable to what was observed in the US pivotal study and to more accurately determine the rates of certain serious adverse events so that this information can be used to inform patient labeling.

Subjects in the open label, multi-center study will receive dietary/exercise counseling plus the Spatz3 Adjustable Balloon System for 32 weeks.

Eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz3 Adjustable Balloon System for 32 weeks. All subjects ...

The purpose of this study is to compare weight loss, improvement of comorbidities, improvement of lipid profile, blood sugar in patients undergoing endoscopic sleeve gastroplasty or intragastric balloon between patients who are in a weight loss program and those who are not.

The purpose of this study is to understand changes in gastric electrical activity and gastric emptying in response to the Spatz3 balloon and evaluate if baseline measurement of these gastric physiological changes can predict response to treatment, and to understand the impact that balloon volume adjustment after weight loss plateau has on gastric electrical activity and emptying and correlate these changes with effectiveness of the balloon volume adjustment in resulting in further weight loss after the balloon.

The primary aim is to study the correlation between changes in the gut microbiome of obese subjects undergoing an intragastric balloon procedure.

The purpose of this study is to investigate the change in quality of life after endoscopic bariatric therapies and to correlate the changes in quality of life with changes in weight after endoscopic bariatric Therapies (EBTs).

The purpose of this study is to assess if a larger interventional study is possible.  This study will follow subjects wearing a small device  that sticks to the skin temporarily to collect vitals information. This information is routed by 4G/5G wireless technology to a secured data system on the internet accessable by study team and funding sponsor personnel without any personally identifiable information for the assessment of connectivity, accuracy, and usefullness as compared to current health monitoring systems in clinical use both on-site at the hospital and at home.