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NCT05578703 · ClinicalTrials.gov registry record · NA
ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)
A NA study of Obesity, sponsored by True You Weight Loss.
- Active
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05578703: Active NA study of Obesity, sponsored by True You Weight Loss.
NCT05578703 is a NA study of Obesity that is active but no longer recruiting, run by True You Weight Loss. The registered enrollment target is 10 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05578703, a NA study of Obesity, is active but no longer recruiting, sponsored by True You Weight Loss.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty
- DEVICE Fundic Mucosal Ablation with ERBE HybridAPC
- DEVICE Apollo ESG
Study Locations (1)
North Carolina
- True You Weight Loss - Cary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-11-09 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05578703
The ClinicalTrials.gov registry entry for NCT05578703 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower). The listed sponsor is True You Weight Loss, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty is the first listed.
NCT05578703 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05578703 about?
NCT05578703 is a clinical study titled "ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)". 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). Th...
What is the current status of trial NCT05578703?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2022-11-09. Estimated completion is 2026-06.
What conditions does trial NCT05578703 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT05578703?
The interventions under investigation include: Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty (PROCEDURE), Fundic Mucosal Ablation with ERBE HybridAPC (DEVICE), Apollo ESG (DEVICE).
Who is sponsoring clinical trial NCT05578703?
This trial is sponsored by True You Weight Loss, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05578703 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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