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Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy

NCT05486338 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-22

No results posted yet for this 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

Interventions

DEVICE

Hybrid Argon Plasma Coagulation (HAPC)

Gastric mucosal ablation is an endoscopic procedure which uses argonplasma coagulation in combination with submucosal injection to achieve selective ablation to the gastric mucosa and preventing thermal damage to the muscle layer.

Sponsors & Collaborators

  • Erbe USA Incorporated

    collaborator OTHER

  • Erbe Elektromedizin GmbH

    lead INDUSTRY

Principal Investigators

  • Dilhana Badurdeen, MBBS · Mayo Clinic, Jacksonville, Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2025-04-18
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05486338 on ClinicalTrials.gov