Clinical Research Directory

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and hepatocellular carcinoma. In 2017, the lifetime costs of caring for NASH patients in the U.S. were estimated at $222.6 billion, with the cost of caring for the advanced NASH (fibrosis stage ≥ 3) being $95.4 billion. It is projected that the number of NASH cases will increase by 63% from 2015 to 2030. Given the weight loss efficacy of Endoscopic Bariatric and Metabolic Therapies (EBMTs), it has been suggested that EBMTs may serve as a novel treatment category for NASH. Previously, the PI and Co-Is studied the effect of Intragastric balloons (IGB)-the oldest EBMT device-on NASH. EUS liver biopsy performed at the time of IGB removal revealed resolution of all NASH histologic features including fibrosis. A follow-up study by a different group showed similar findings. Furthermore, studies have showed the benefits of S-ESG and Aspiration Therapy (AT) on non-histologic features of NASH. Given the greater weight loss experienced after P-ESG compared to IGB (20% vs 10% TWL) and the more reproducible technique and shorter learning curve of the current P-ESG compared to S-ESG, we aim to assess the effect of P-ESG on NASH.

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition. 1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy. 1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS).

Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates

The aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects (≥35 kg/m2) with end stage renal disease who need of kidney transplantation to reduce their BMI below 35 in order to be inserted in the waiting list BMI. The main question\[s\] it aims to answer are: Is the procedure effective in reducing BMI to the target level in 12 months? Which is the effect on weight loss, quality of life and obesity-related comorbidities? Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation.