Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420700
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-14
Brief Title:
Ablation Registry Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss
Sponsor:
True You Weight Loss
Organization:
True You Weight Loss
Study Overview
Official Title:
A Multi-site Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss
Status:
RECRUITING
Status Verified Date:
2024-05
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 construct a multi-site prospective registry to evaluate the clinical outcomes of patients who have undergone combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss
Detailed Description:
Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interventions The endoscopic sleeve gastroplasty ESG is a per oral gastric remodeling technique that employs full-thickness suturing to imbricate the stomach along the greater curvature to achieve a restricted sleeve-like configuration While the ESG recapitulates the configuration of a gastric sleeve it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy LSG A major difference between ESG and LSG is that the former does not involve the gastric fundus The proximal stomach and the fundus in particular produces ghrelin the only known orexigenic hormone which has been linked to increased calorie intake and weight gain Studies have observed reduced levels of ghrelin along multiple timepoints following LSG and this has been attributed to targeting of the fundus as bariatric surgeries that did not involve the fundus did not see a decrease in circulating plasma ghrelin In contrast in a small comparative study of ESG and LSG patients who had undergone ESG did not show any decrease in fasting ghrelin levels ostensibly due to fundic-sparing In a preliminary first-in-human study conducted by True You Weight Loss ABLATE Weight gastric fundus ablation via hybrid argon plasma coagulation was followed sequentially by ESG after 6 months In this 10-patient study fundus ablation was performed safely in all cases and without serious adverse events A subsequent first-in-human study ABLATE WEIGHT 2 further investigated gastric fundus ablation in a single-stage approach by combining fundus ablation and ESG during the same endoscopic session Preliminary data revealed enhanced clinical effectiveness for the single-stage approach when compared to traditional endoscopic sleeve gastroplasty while maintaining a clinically feasible safety profile By constructing a multi-site prospective registry the investigators aim to longitudinally collect and assess the clinical outcomes and characteristics of patients undergoing combined gastric mucosal ablation with endoscopic sleeve gastroplasty ESG at True You Weight Loss
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None