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ACTIVE NOT RECRUITING
NCT05870943
NA

Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Validation Study

Sponsor: True You Weight Loss

View on ClinicalTrials.gov

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.

Official title: Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial: A Single-Center Randomized Controlled Validation Trial in a Community Setting

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2023-05-18

Completion Date

2025-05

Last Updated

2024-04-08

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Hybrid Argon Plasma Coagulation

Hybrid APC will be utilized to first ablate the gastric mucosa along the greater curve of the stomach.

PROCEDURE

Endoscopic Sleeve Gastroplasty

Endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.

Locations (1)

True You Weight Loss

Cary, North Carolina, United States