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Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Validation Study

NCT05870943 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-04-08

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Erbe USA Incorporated

    collaborator OTHER

  • Erbe Elektromedizin GmbH

    collaborator INDUSTRY

  • True You Weight Loss

    lead OTHER

Principal Investigators

  • Christopher E McGowan, MD, MSCR · CEO/Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2025-03-31
Completion
2025-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870943 on ClinicalTrials.gov