CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 10 target
Drug / intervention
Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05578703
NCT05578703N/AActiveUpdate OverdueUpdated 25mo ago · Completion was 7mo ago
Enrollment Stalled

Gastric Fundus Ablation Plus Endoscopic Sleeve Gastroplasty for Weight Loss

True You Weight Loss·interventional·Posted Oct 13, 2022·Updated May 14, 2024

In Brief

A clinical study evaluating Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty, Fundic Mucosal Ablation with ERBE HybridAPC, and 1 other intervention for Obesity. Active but no longer recruiting, targeting 10 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of this research is to investigate the effects of fundic ablation (FA) 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. The fundic mucosal ablation is not typically done prior to the endoscopic sleeve gastroplasty procedure. When fundic mucosal ablation is sequentially 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 should be made available to patients as part of a comprehensive weight loss strategy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/AActiveOverdue
2023202420252026
First PostedOct 13, 2022
Enrollment StartNov 9, 2022
Primary CompletionDec 1, 2025
Study CompletionJun 1, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 3.7 years ago

Interventions

Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplastyprocedure

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

Fundic Mucosal Ablation with ERBE HybridAPCdevice

Fundic mucosal ablation utilizing approved ERBE HybridAPC

Apollo ESGdevice

Using only Apollo ESG as approved per label