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ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss)

NCT05992103 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-12-07

No results posted yet for this study

Summary

The purpose of this research is to investigate the combined effects of fundic ablation (FA) and endoscopic sleeve gastroplasty on circulating plasma ghrelin, satiation, and total body weight loss, as well as the incidence of adverse events. This procedure will be carried out with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument creates an electric current to deliver a safe amount of thermal injury to a portion of the stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin which is the only known hormone linked to increasing appetite, calorie intake, and weight gain. This procedure is designed to target the bodily effects of appetite control and gastric sensory and motor functions which cause the feeling of fullness and satiation. When fundic mucosal ablation is paired with endoscopic sleeve gastroplasty (ESG), this combined investigational approach may lead to decreased fasting ghrelin levels, improved satiation, and greater total body weight loss than traditional ESG. This study will help determine if the combined impact of FA with ESG within the same endoscopic session should be made available to patients as part of a comprehensive weight loss strategy.

Conditions

Interventions

PROCEDURE

Fundic Ablation in Combination with Endoscopic Sleeve Gastroplasty

Fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the treatment of adults with obesity

DEVICE

Fundic Mucosal Ablation with ERBE HybridAPC

Fundic mucosal ablation utilizing approved ERBE HybridAPC

DEVICE

Apollo ESG

Using only Apollo ESG as approved per label

Sponsors & Collaborators

  • True You Weight Loss

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2025-04-14
Completion
2025-05-15
FDA Device
Yes

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 NCT05992103 on ClinicalTrials.gov