Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299644
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-01
Brief Title:
Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device A Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body Therefore in this pilot study the investigators aim to compare belt with belt and suspenders plication pattern using the Endomina system to determine percent total weight loss
Detailed Description:
Obesity is a major global health concern In the US from 1999 through 2020 the prevalence of obesity has increased from 305 to 419 Obesity defined as the body mass index of more than 30 kgm2 increases the risk of metabolic diseases and has become the leading cause of death including cardiovascular disease stroke and cancers
At present obesity treatment ranges from lifestyle modification pharmacotherapy endoscopic to surgical intervention Though bariatric surgery has proven to be the most effective treatment in terms of weight loss it still carries the complication rates of 06 - 49
Endoscopic Bariatric and Metabolic Therapy EBMT has emerged as an alternative minimally invasive approach for the patients with morbid obesity with the body mass index BMI of 30 - 40 kgm2 Endoscopic sleeve gastroplasty ESG involves placing sutures inside the stomach using an endoluminal full-thickness suturing device This allows for gastric volume reduction and impaired gastric motility which results in weight loss Recent meta-analysis demonstrated ESG using OverStitch suturing device percent total weight loss TWL of 1609 - 1643 at 12 months after procedure and a serious adverse event rate of 1 - 226 With favorable outcomes and lower complication rates compared to bariatric surgery ESG has been growing in popularity and increasingly performed worldwide Other EBT cleared by the US Food and Drug Administration for full thickness tissue approximation include the Incisionless Operating Platform endoscopic plication USGI Medical San Clemente Calif USA and Endomina Endo Tools Therapeutic Gosselies Belgium which creates gastric plications
Currently there is no standardization regarding suturing patterns One suture pattern for gastric plication that has been used is the belt and suspenders pattern whereby plications sutures are placed in the distal gastric body along the width belt and midproximal gastric body suspenders This allows for gastric shortening and reduction in gastric volume It is suspected this would also alter gastric motility The distal gastric plications placed near the antrum would result in a disruption of gastric motility decreased gastric motility would result in decrease gastric emptying and longer satiety
At present obesity treatment ranges from lifestyle modification pharmacotherapy endoscopic to surgical intervention Though bariatric surgery has proven to be the most effective treatment in terms of weight loss it still carries the complication rates of 06 - 49
Endoscopic Bariatric and Metabolic Therapy EBMT has emerged as an alternative minimally invasive approach for the patients with morbid obesity with the body mass index BMI of 30 - 40 kgm2 Endoscopic sleeve gastroplasty ESG involves placing sutures inside the stomach using an endoluminal full-thickness suturing device This allows for gastric volume reduction and impaired gastric motility which results in weight loss Recent meta-analysis demonstrated ESG using OverStitch suturing device percent total weight loss TWL of 1609 - 1643 at 12 months after procedure and a serious adverse event rate of 1 - 226 With favorable outcomes and lower complication rates compared to bariatric surgery ESG has been growing in popularity and increasingly performed worldwide Other EBT cleared by the US Food and Drug Administration for full thickness tissue approximation include the Incisionless Operating Platform endoscopic plication USGI Medical San Clemente Calif USA and Endomina Endo Tools Therapeutic Gosselies Belgium which creates gastric plications
Currently there is no standardization regarding suturing patterns One suture pattern for gastric plication that has been used is the belt and suspenders pattern whereby plications sutures are placed in the distal gastric body along the width belt and midproximal gastric body suspenders This allows for gastric shortening and reduction in gastric volume It is suspected this would also alter gastric motility The distal gastric plications placed near the antrum would result in a disruption of gastric motility decreased gastric motility would result in decrease gastric emptying and longer satiety
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