Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870943
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-04-24
Brief Title:
Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Validation Study
Sponsor:
True You Weight Loss
Organization:
True You Weight Loss
Study Overview
Official Title:
Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial A Single-Center Randomized Controlled Validation Trial in a Community Setting
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
HAPCET2
Brief Summary:
The purpose of this research is to evaluate the clinical safety durability and weight loss outcomes of the hybrid argon plasma coagulation endoscopic sleeve gastroplasty HAPC-ESG procedure when compared to traditional endoscopic sleeve gastroplasty ESG alone ESG was proven to be feasible in human subjects in 2013 and since then has become the most commonly performed endoscopic bariatric remodeling procedure However this procedure may be enhanced with the addition of the hybrid argon plasma coagulation HAPC technique leading to enhanced weight loss durability and metabolic benefits Argon plasma coagulation APC is a method of non-contact thermal hemostasis initially created to assist in inducing hemostasis utilizing a high-frequency current to the targeted area This is a validation study of a pilot randomized control trial which will evaluate the safety durability and effects on weight loss of the combined HAPC-ESG approach when compared to traditional ESG alone
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 Argon Plasma Coagulation APC is a method of non-contact thermal hemostasis which utilizes a high-frequency current applied to the target tissue through an argon plasma jet to induce hemostasis and a homogenous surface coagulation with a limited depth of penetration APC is a widely used therapy in the luminal digestive tract to provide non-contact targeted thermal injury for mucosal ablation and may therefore allow for a greater submucosal component of healing between tissue plications and consequently greater durability of the gastroplasty Enhanced fibrosis along the site of endoscopic plications with the addition of APC could decrease the incidence of weight regain in patients undergoing ESG and capitalize on the metabolic benefits of gastric mucosal revitalization reported with APC alone In this study the investigators propose to evaluate the durability of endoscopic plications weight loss outcomes and improvements in obesity related co-morbidities for the combined hybrid argon plasma coagulation plus endoscopic sleeve gastroplasty HAPC-ESG procedure when compared to traditional ESG Investigators hypothesize that HAPC-ESG will provide greater durability of the gastroplasty construct than traditional ESG This is a single-center randomized single-blinded clinical trial evaluating the efficacy and safety of HAPC-ESG for weight loss and improvement in obesity-related co-morbidities compared to ESG alone The study population includes adult patients who are seeking ESG at True You Weight Loss in Cary NC with a BMI 30 and 40 kgm² who have failed to achieve and maintain weight loss with a non-surgical management
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