Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05486338
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2022-08-01
Brief Title:
Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy
Sponsor:
Erbe Elektromedizin GmbH
Organization:
Erbe Elektromedizin GmbH
Study Overview
Official Title:
Endoscopic Gastric Mucosal Ablation GMA as a Primary Obesity Therapy Early Feasibility COMET EF - Step II
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMET
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None