Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05763485
Status:
RECRUITING
Last Update Posted:
2023-03-10
First Post:
2023-02-09
Brief Title:
Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD a Prospective Randomized Single-blinded Sham-controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-03
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:
APDG
Brief Summary:
This is a prospective randomized single-blinded interventional controlled trial to evaluate the efficacy and safety of endoscopic anti reflux mucosal ablation ARMA in PPI dependent gastroesophageal reflux disease GERD in comparison to controls with a sham procedure
Detailed Description:
Patients who fulfill the inclusion criteria and after informed consent are willing to participate in this study will be prepared for ARMA After sedation the patients will be randomized equally into an intervention and control Group The patients are blinded to the procedure The Patients in the intervention group receive ARMA using argon plasma coagulation APC at the gastroesophageal junction EGJ in two semicircular patterns while the control group receives a sham procedure The approximate duration of the procedure is 30min After the procedure the patients receive follow up controls at 2 4 6 and 12 months During the first follow up 2 months after the procedure symptoms are evaluated by questionnaires GERD- HRQL FSSG VAG Subsequently the PPI- medication is stopped in all patients until the end of the study or worsening of symptoms During the second follow up 4 months after the initial procedure the symptoms are reevaluated by questionnaires The patients are then unblinded and are told if they received ARMA or sham procedure Those patients who received ARMA are examined by esophagogastroduodenoscopy esophageal manometry and pH metry Further assessments is performed by questionnaires 6 and 12 months after the initial procedure
Those patients in the control group are allowed to take part in a crossover to receive the ARMA procedure as well If they receive ARMA symptoms are reevaluated 2 months after the procedure by questionnaires esophagogastroduodenoscopy esophageal manometry and pH metry Further controls are performed after 4 6 and 12 months by questionnaires
Those patients in the control group are allowed to take part in a crossover to receive the ARMA procedure as well If they receive ARMA symptoms are reevaluated 2 months after the procedure by questionnaires esophagogastroduodenoscopy esophageal manometry and pH metry Further controls are performed after 4 6 and 12 months by questionnaires
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