Obesity Clinical Trial
Official title:
Endoscopic Gastric Mucosal Ablation (GMA) as a Primary Obesity Therapy Early Feasibility [COMET EF] - Step II
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.
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| NCT number | NCT05486338 |
| Study type | Interventional |
| Source | Erbe Elektromedizin GmbH |
| Contact | Jan Miller, RN, CCRA |
| Phone | 800-778-3723 |
| [email protected] | |
| Status | Not yet recruiting |
| Phase | N/A |
| Start date | December 2022 |
| Completion date | March 2025 |
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