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Endoscopic Sleeve Gastroplasty clinical trials

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NCT ID: NCT06339320 Recruiting - Obesity Clinical Trials

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

Start date: February 28, 2024
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT05917795 Recruiting - Clinical trials for End Stage Renal Disease

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

ESGiTXKidney
Start date: September 24, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04820036 Recruiting - Obesity Clinical Trials

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

Start date: May 6, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04452786 Withdrawn - Clinical trials for Glucose Metabolism Disorders

Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Start date: June 5, 2020
Phase: N/A
Study type: Interventional

The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).

NCT ID: NCT04264364 Completed - Obesity Clinical Trials

ESG vs LSG: Short-term Nutritional Outcomes

Start date: June 16, 2019
Phase:
Study type: Observational

To assess endoscopic sleeve gastroplasty in comparison to laparoscopic sleeve gastrectomy before and 3 months after the procedure in terms of multiple nutrition-related factors, quality of life, weight and other related parameters.

NCT ID: NCT04200144 Recruiting - Obesity Clinical Trials

Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial

ESGORT
Start date: February 4, 2020
Phase: N/A
Study type: Interventional

This is an interventional, open-label, randomized (2:1), standard medical therapy-controlled trial. Subjects in the standard therapy group will be given the opportunity to undergo the active endoscopic treatment after 6 months of follow up (open label extension) if they will not achieve an adequate result on body weight. All patients will be followed until the planned end of the study after 36 months from the ESG procedure. To study the effects of endoscopic gastroplasty on weight, metabolic risk factors, quality of life, satiety, gastrointestinal motility and gut microbiota compared to standard medical treatment control group. Primary endpoint: - Total body weight loss (%) Secondary endpoints: - Metabolic risk factors (e.g. lipid profile) and anthropometric measurements (e.g hip and waist circumference) - Body composition - Quality of life - Gastroesophageal reflux disease - Non-Alcoholic Fatty Liver Disease (NAFLD) - Non- Alcoholic-Steato-Hepatitis (NASH) - Satiety - Gut microbiota Exploratory endpoints: - Gut hormones e.g. glucagon-like peptide 1, PYY and ghrelin - Gastrointestinal motility

NCT ID: NCT03626194 Recruiting - Clinical trials for Endoscopic Sleeve Gastroplasty

Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

Start date: December 12, 2016
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT03124485 Not yet recruiting - Clinical trials for Endoscopic Sleeve Gastroplasty

Endoscopic Sleeve Gastroplasty for Morbid Obesity

Start date: August 2017
Phase: N/A
Study type: Interventional

Obesity and its related metabolic disorders are increasingly a heavy health burden to many parts of the world. Weight control is a well-known important step in avoiding type 2 diabetes mellitus (T2DM). It is also an essential component for normalizing the blood glucose and preventing macrovascular and microvascular insults to patients with diagnosed T2DM. However, life-style modification, physical exercise and dietary adjustment are ineffective measures which are unlikely to confer adequate and sustainable weight loss for the truly obese. On the other hand, large scale long-term follow-up studies have confirmed the role of bariatric surgery in providing durable weight loss and remarkable improvement on medical comorbidities. Among all the bariatric operations, laparoscopic sleeve gastrectomy (LSG) is currently the most widely adopted procedure worldwide because of its simplicity and effectiveness in weight reduction. However, LSG is not without risk. Staple-line hemorrhage, leakage and stenosis are potentially life-threatening complications. LSG is also costly because of the need for expensive laparoscopic staplers.