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NCT05486338 · ClinicalTrials.gov registry record · NA
Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy
A NA study of Obesity and Adiposity, sponsored by Erbe Elektromedizin.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT05486338: Active NA study of Obesity and Adiposity, sponsored by Erbe Elektromedizin.
NCT05486338 is a NA study of Obesity and Adiposity that is active but no longer recruiting, run by Erbe Elektromedizin. The registered enrollment target is 15 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05486338, a NA study of Obesity and Adiposity, is active but no longer recruiting, sponsored by Erbe Elektromedizin.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure. Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC. As primary objective total body weight loss (TBWL) will be determined as body weight difference at the 6 months follow up (FU) visit after the last treatment session in comparison to the body weight prior to the initial treatment. After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed. After the treatments the participants will be followed for up to 12 months to assess the outcome of the GMA procedure.
Primary Outcome
Primary endpoint will be determined as the % of total body weight loss (TBWL). Total body weight loss (TBWL) will be determined as body weight difference at the final 6 months follow up (FU) visit after the last treatment visit in comparison to the body weight prior to the first treatment.
Interventions
- DEVICE Hybrid Argon Plasma Coagulation (HAPC)
Study Locations (2)
Florida
- Mayo Clinic - Jacksonville
North Carolina
- True You Weight Loss - Cary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2026-03 |
| Phase | NA |
What the registry record for NCT05486338 still lists
NCT05486338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Hybrid Argon Plasma Coagulation (HAPC) is the first listed.
NCT05486338 reports a single indexed study location in Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05486338 about?
NCT05486338 is a clinical study titled "Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy". This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure. Previous studies have suggested that weight loss after vertical sleeve gastr...
What is the current status of trial NCT05486338?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2023-09-05. Estimated completion is 2026-03.
What conditions does trial NCT05486338 study?
This clinical trial studies the following conditions: Obesity, Adiposity.
What interventions are being tested in trial NCT05486338?
The interventions under investigation include: Hybrid Argon Plasma Coagulation (HAPC) (DEVICE).
Who is sponsoring clinical trial NCT05486338?
This trial is sponsored by Erbe Elektromedizin, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05486338 being conducted?
This trial has 2 study locations across Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05486338's enrollment target sits among peer trials
15 999th of 1053 higher than 46 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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