Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745012
Status:
RECRUITING
Last Update Posted:
2023-02-27
First Post:
2022-09-05
Brief Title:
Anti-Reflux Mucosectomy in the Treatment of Refractory Gastro-esophageal Reflux
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Anti-Reflux Mucosectomy ARMS in the Treatment of Refractory Gastro-esophageal Reflux GERD a Prospective Randomized Comparative Study
Status:
RECRUITING
Status Verified Date:
2023-02
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:
MARRGO
Brief Summary:
Gastroesophageal reflux disease GERD is one of the most common digestive diseases in Western countries affecting 8 of the population in its typical and frequent form For typical GERD without alarming symptoms treatment combines PPI therapy and lifestyle modifications Patients with an incomplete response to optimized PPI therapy have so-called refractory GERD Anti-reflux mucosectomy ARMS is a recent technique that achieves endoscopic fundoplication by scar-induced tissue retraction using a mucosal ligation system combined with resection known as the banded ligation system ARM-b 6 Several studies have shown efficacy of approximately 65-70 on symptom resolution and quality of life improvement including our pilot study of 21 patients and without serious adverse events
The purpose of this study is therefore to prospectively evaluate in a randomized blinded comparison to a sham procedure and conventional medical follow-up the efficacy of anti-reflux mucosectomy ARMS in the treatment of refractory GERD
The hypothesis is that we can achieve a clinical efficacy rate of 65 in the treatment group versus 35 in the control group
The primary objective is to demonstrate the superiority in terms of clinical efficacy self-reported symptom-related GERD rate GERD-SLR of RAS compared to the sham procedure combined with optimized medical treatment at 1 year The primary endpoint will be clinical efficacy defined as a greater than 50 decrease in the number of GERD-associated symptoms assessed using the GERD-HRQL score
Secondary objectives will be
Assessing clinical efficacy at 6 months Assess the impact on PPI use Assess changes in procedure-induced abnormal esophageal acid exposure by Ph-metry Assess the impact of this technique on patient quality of life To document the adverse effects of the technique AGREE Clavien Dindo and ASGE score The duration of follow-up will be 1 year and based on our hypothesis the number of patients to be included will be 130
The purpose of this study is therefore to prospectively evaluate in a randomized blinded comparison to a sham procedure and conventional medical follow-up the efficacy of anti-reflux mucosectomy ARMS in the treatment of refractory GERD
The hypothesis is that we can achieve a clinical efficacy rate of 65 in the treatment group versus 35 in the control group
The primary objective is to demonstrate the superiority in terms of clinical efficacy self-reported symptom-related GERD rate GERD-SLR of RAS compared to the sham procedure combined with optimized medical treatment at 1 year The primary endpoint will be clinical efficacy defined as a greater than 50 decrease in the number of GERD-associated symptoms assessed using the GERD-HRQL score
Secondary objectives will be
Assessing clinical efficacy at 6 months Assess the impact on PPI use Assess changes in procedure-induced abnormal esophageal acid exposure by Ph-metry Assess the impact of this technique on patient quality of life To document the adverse effects of the technique AGREE Clavien Dindo and ASGE score The duration of follow-up will be 1 year and based on our hypothesis the number of patients to be included will be 130
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None