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Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy
NCT05486338 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05486338
The ClinicalTrials.gov registry entry for NCT05486338 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Erbe Elektromedizin, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05486338 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05486338?
The interventions under investigation include: Hybrid Argon Plasma Coagulation (HAPC) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05486338?
This trial is sponsored by Erbe Elektromedizin, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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