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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 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.

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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.

Conditions Studied

Obesity Adiposity

Interventions

  • DEVICE Hybrid Argon Plasma Coagulation (HAPC)

Study Locations (2)

Florida

  • Mayo Clinic - Jacksonville

North Carolina

  • True You Weight Loss - Cary

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2023-09-05
Est. Completion 2026-03
Phase NA

Sponsor

Erbe Elektromedizin

2 total trials

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What the Registry Record Tells You About NCT05486338

The ClinicalTrials.gov registry entry for NCT05486338 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 15 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 (98% lower). The listed sponsor is Erbe Elektromedizin, which has 2 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.