Barham K. Abu Dayyeh, M.D., M.P.H.

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 evaluate a treatment for obesity.

To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component >30%.

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 will follow a 1000-1200 kcal/day-deficit diet during their participation in the study.

At 18 weeks ±4 weeks, subjects will be evaluated, and those that meet the criteria described below in section 4.3.3.2.4 will undergo an adjustment procedure wherein the balloon volume will be increased to achieve extra weight loss. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure.

At the end of the 32-week treatment period, all subjects who lost at least 5% Total Body Weight Loss (TBWL) prior to device removal will be followed for an additional 6 months. In addition, patients with device- and/or procedure-related adverse events will be followed until resolution of the event.

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.

This registry is intended as an observational, post-marketing surveillance tool. The purpose of this registry is to collect baseline demographics and user experience of the commercially available MUSE (Medigus Ultrasonic Endostapler) system for the treatment of gastroesophageal reflux disease. The data collection aims to gather a minimum of 3 years follow-up on a large number of subjects during use of the system outside of a prescribed clinical study.

The purpose of this study is to learn more about the effects of similar weight loss through caloric restriction, gastric reduction, and bypass of the proximal small intestines on gut microbiota and compare them to changes in the microbiome of obese subjects undergoing sham procedures and life-style modification.

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 evaluate the usefulness of combining a core liver biopsy guided by endoscopic ultrasound and stomach balloon placement by endoscope for the diagnosis and treatment of fatty liver disease and obesity.

The purpose of this study is to evaluate the safety and effectiveness of coxial lumen apposing metal stents in patients with strictures (narrowing) within the gastrointestinal tract.

The aim of this study is to compare baseline, early post-procedural (2 month), and delayed post-procedural (6 month) T1/2, as assessed by both GEBT and NSSM, in seven adult subjects with obesity who have underwent an Endoscopic Gastric Remodeling Weight Loss procedure (EGRWL).  

The proposed study is a prospective, pilot study to assess the feasibility of a novel endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for the primary treatment of obesity. The investigators aim to recruit ten subjects with a body mass index between 30-40 for this study. Vertical sutures will be performed using the endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum toxin(approximately 30 units) will be injected around the sutures insertion sites in half of the subjects randomly to slow down muscular grinding of the stomach to see if it improves durability of the procedure.

The purpose of this study is to gather information on the best technique to manage necrotic (decaying) tissue of the pancreas between two acceptable endoscopic choices currently being used.

This study will review and analyze the literature regarding endoscopic revision of Roux-en-Y gastric bypass surgery for the treatment of weight regain using the OverStitch, a minimally invasive endoscopic device. This study will also include information about patients who underwent TORe as part of their clinical evaluation and treatment for weight regain by chart review.

The purpose of this study is to collect data related to patients undergoing diagnostic evaluation and treatment of Gastroesophageal Reflux Disease (GERD) and its associated diseases in multiple academic and community settings.

Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endolumenally placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction. Up to 200 participants at 8 locations in the United States will participate in this study. The ESG procedure has been performed clinically for 3 years in the United States. We are completing this study to compare how effective the ESG is for achieving long-term weight loss when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life. Results of this research may help support having this procedure covered by health insurance plans for future patients

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 track endoscopically-placed stents and demonstrate that either suturing pattern is equivalent.

This study is being done to understand the short and long term changes in gastric emptying in response to the endoscopic sleeve gastroplasty (ESG).

The purpose of this study is to explore the effectiveness and safety of a modified gastroplication technique for weight loss in five patients with obesity, and includes physiologic appraisal of gastric emptying (via gastric emptying breath test) and post-prandial gastric accommodation (via SPECT).

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.