Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339320
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-11
Brief Title:
Endoscopic Sleeve Gastroplasty ESG for the Treatment of Obesity
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Endoscopic Sleeve Gastroplasty ESG for the Treatment of Obesity
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate endoscopic sleeve gastroplasty ESG for the treatment of obesity The ESG procedure is an US Food and Drug Administration FDA approved procedure for the treatment of obesity - patients with a body mass index BMI 30-50 kgm2 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
Detailed Description:
Obesity has become an epidemic on a national and international scale with immense burden of disease Approximately one out of every three United States US adults are characterized as having obesity with the global prevalence having nearly tripled over the last four decades to include over 650 million people Although diet and exercise are essential these interventions alone typically result in only 1-3 total weight loss Pharmacotherapy is effective but has side effects and carries the risk of weight recurrence once discontinued While bariatric surgery is the most robust treatment option only 1 of eligible patients undergo surgery leaving a tremendous need for effective and safe therapies
Helping to bridge this gap in available treatments the endoscopic sleeve gastroplasty ESG procedure provides a way to improve access to validated efficacious and safe anti-obesity treatments ESG is an endoscopic weight loss procedure The procedure uses an endoscopic suturing device which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with obesity BMI 30-50 kgm2 who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70 to 80 its original size Following the procedure the new stomach appears similar to the surgical sleeve stomach although the procedure is considered less invasive with fewer complications compared to a surgical sleeve procedure
This study aims to perform ESG for patients with obesity defined as a BMI 30-50 kgm2 Additionally data collection of relevant weight-related and metabolic outcomes including comorbidity resolution will be collected retrospectively from the study to assess efficacy and safety of the ESG procedure Data collection for the MBSAQIP registry will be recorded on a monthly basis
Helping to bridge this gap in available treatments the endoscopic sleeve gastroplasty ESG procedure provides a way to improve access to validated efficacious and safe anti-obesity treatments ESG is an endoscopic weight loss procedure The procedure uses an endoscopic suturing device which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with obesity BMI 30-50 kgm2 who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70 to 80 its original size Following the procedure the new stomach appears similar to the surgical sleeve stomach although the procedure is considered less invasive with fewer complications compared to a surgical sleeve procedure
This study aims to perform ESG for patients with obesity defined as a BMI 30-50 kgm2 Additionally data collection of relevant weight-related and metabolic outcomes including comorbidity resolution will be collected retrospectively from the study to assess efficacy and safety of the ESG procedure Data collection for the MBSAQIP registry will be recorded on a monthly basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None