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A Study of Endoscopic Intragastric Balloon Placement for Weight Loss in Liver Transplant Waitlist Candidates
Rochester, MN
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.
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ORBERA™ Post-Approval Study
Rochester, MN
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
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A Study To Test The Safety And Effectiveness Of The Spatz3 Adjustable Balloon System To Help Obese People Lose Weight
Rochester, MN
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.
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A Study to Evaluate the Effectiveness of a Healthy Living Weight Loss Program in Obese Patients Undergoing Bariatric Endoscopy on Weight Loss Outcomes
Rochester, MN
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.
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Changes in Gut Microbiota After Placement of Endoscopic Intragastric Balloon
Rochester, MN
The primary aim is to study the correlation between changes in the gut microbiome of obese subjects undergoing an intragastric balloon procedure.
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The Effect of Spatz3 Adjustable Balloon System Plus Diet and Exercise on Gastric Electrical Activity and Emptying
Rochester, MN
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.
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Quality of Life after Endoscopic Bariatric Therapies
Rochester, MN
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).
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Observational Study of Wearable Health Monitoring Device
Rochester, MN
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.