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Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD (APDG)

Primary Purpose

Gastroesophageal Reflux

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Anti reflux mucosal ablation (ARMA)
Sham procedure
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring anti reflux mucosal ablation, ARMA

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: PPI dependent GERD for at least 6 months Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% in pH metry while off PPI Exclusion of primary esophageal motility disorders by manometry Upper endoscopy with biopsy (Exclusion of eosinophilic esophagitis) Exclusion Criteria: Sliding hiatal hernia >3cm Los Angeles grade C/D esophagitis Primary esophageal motility disorders Grade IV Hill´s flap valve Pregnancy or planed pregnancy in the next 12 months Eosinophilic esophagitis Paraesophageal hernia Previous esophageal or gastric surgery Barretts esophagus Liver cirrhosis Varices Lack of consent ASA physical status >III

Sites / Locations

  • II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Anti reflux mucosal ablation (ARMA)

Sham procedure

Arm Description

Patients randomized into the intervention arm receive ARMA and a follow up control after 2, 4, 6 and 12 months. PPI treatment is stopped after 2 months until the end of the study or worsening of symptoms. Esophagogastroduodenoscopy, manometry and pH metry is performed after 4 months.

Patients randomized into the sham procedure arm receive a esophagogastroduodenoscopy in the same setting as if ARMA would be performed. Patients in the Control group receive follow up controls after 2 and 4 months and after unblinding after 4 months are allowed to perform a crossover to receive ARMA. PPI treatment is stopped 2 months after the initial sham procedure until the end of the study or worsening of symptoms. If the patients receive ARMA as a crossover reevaluation is performed 2, 4, 6 and 12 months after the actual ARMA procedure.

Outcomes

Primary Outcome Measures

Improvement in symptoms of gastro esophageal reflux disease
Improvement in symptoms of gastro esophageal reflux disease by more than 50% from baseline in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 4 months after procedure. Total score 0-50; higher scores indicate greater complaints.

Secondary Outcome Measures

Change in symptoms of gastro esophageal reflux disease
Change in symptoms of gastro esophageal reflux disease in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 6 and 12 months. Total score 0-50; higher scores indicate greater complaints.
Change in symptoms of gastro esophageal reflux disease
Change in symptoms of gastro esophageal reflux disease in regurgitation score at 4, 6 and 12 months. Total score 0-30; higher scores indicate greater complaints.
Change in symptoms of gastro esophageal reflux disease
Change in symptoms of gastro esophageal reflux disease in Frequency scale for the symptoms of GERD (FSSG) at 4, 6 and 12 months. Total score 0-48; higher scores indicate greater complaints.
Change in symptoms of gastro esophageal reflux disease
Change in symptoms of gastro esophageal reflux disease in visual analog scale (VAS) at 4, 6 and 12 months. Total score 0-10; higher scores indicate greater complaints.
Complication rate
Recording of all complications in relation to the ARMA- procedure
PPI dependency
Requirement and dose of PPI at 4, 6 and 12 months
Change in esophageal acid exposure at 4 months after ARMA
Change in esophageal acid exposure in pH metry 4 months after ARMA
Change in lower esophageal sphincter pressure 4 months after ARMA
Change in lower esophageal sphincter pressure in manometry 4 months after ARMA
Postinterventional pain
Recording of postinterventional pain in visual analog scale (VAS). Higher scores indicate greater complaints.
Changes in cardia morphology
Changes in Hill's flap grade
Technical success rate
Successful completion of ARMA

Full Information

First Posted
February 9, 2023
Last Updated
March 8, 2023
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT05763485
Brief Title
Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD
Acronym
APDG
Official Title
Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD: a Prospective Randomized, Single-blinded, Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
anti reflux mucosal ablation, ARMA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
4 months after the initial procedure (ARMA or sham-procedure) patients are unblinded. Patients who initially received the sham procedure are now allowed to be treated by ARMA.
Masking
Participant
Masking Description
Patients are randomized equally into an intervention and control group. The patients remain blinded to the procedure until 4 months after the initial procedure.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti reflux mucosal ablation (ARMA)
Arm Type
Active Comparator
Arm Description
Patients randomized into the intervention arm receive ARMA and a follow up control after 2, 4, 6 and 12 months. PPI treatment is stopped after 2 months until the end of the study or worsening of symptoms. Esophagogastroduodenoscopy, manometry and pH metry is performed after 4 months.
Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
Patients randomized into the sham procedure arm receive a esophagogastroduodenoscopy in the same setting as if ARMA would be performed. Patients in the Control group receive follow up controls after 2 and 4 months and after unblinding after 4 months are allowed to perform a crossover to receive ARMA. PPI treatment is stopped 2 months after the initial sham procedure until the end of the study or worsening of symptoms. If the patients receive ARMA as a crossover reevaluation is performed 2, 4, 6 and 12 months after the actual ARMA procedure.
Intervention Type
Procedure
Intervention Name(s)
Anti reflux mucosal ablation (ARMA)
Intervention Description
In patients fulfilling the inclusion criteria and being randomized for ARMA, the procedure using argon plasma coagulation involves two semicircular ablations of the mucosa of the EGJ in a butterfly shape of a width of 2 cm. The approximate duration of the procedure is 30min. Follow includes objective evaluation of reflux disease by reflux questionnaires, esophagogastroduodenoscopy, esophageal manometry, pH metry.
Intervention Type
Procedure
Intervention Name(s)
Sham procedure
Intervention Description
In patients fulfilling the inclusion criteria and being randomized for sham procedure, the procedure involves esophagogastroduodenoscopy with the same set of movements and duration as the ARMA procedure without the actual ablation.
Primary Outcome Measure Information:
Title
Improvement in symptoms of gastro esophageal reflux disease
Description
Improvement in symptoms of gastro esophageal reflux disease by more than 50% from baseline in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 4 months after procedure. Total score 0-50; higher scores indicate greater complaints.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in symptoms of gastro esophageal reflux disease
Description
Change in symptoms of gastro esophageal reflux disease in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 6 and 12 months. Total score 0-50; higher scores indicate greater complaints.
Time Frame
12 months
Title
Change in symptoms of gastro esophageal reflux disease
Description
Change in symptoms of gastro esophageal reflux disease in regurgitation score at 4, 6 and 12 months. Total score 0-30; higher scores indicate greater complaints.
Time Frame
12 months
Title
Change in symptoms of gastro esophageal reflux disease
Description
Change in symptoms of gastro esophageal reflux disease in Frequency scale for the symptoms of GERD (FSSG) at 4, 6 and 12 months. Total score 0-48; higher scores indicate greater complaints.
Time Frame
12 months
Title
Change in symptoms of gastro esophageal reflux disease
Description
Change in symptoms of gastro esophageal reflux disease in visual analog scale (VAS) at 4, 6 and 12 months. Total score 0-10; higher scores indicate greater complaints.
Time Frame
12 months
Title
Complication rate
Description
Recording of all complications in relation to the ARMA- procedure
Time Frame
12 months
Title
PPI dependency
Description
Requirement and dose of PPI at 4, 6 and 12 months
Time Frame
12 months
Title
Change in esophageal acid exposure at 4 months after ARMA
Description
Change in esophageal acid exposure in pH metry 4 months after ARMA
Time Frame
4 months after ARMA
Title
Change in lower esophageal sphincter pressure 4 months after ARMA
Description
Change in lower esophageal sphincter pressure in manometry 4 months after ARMA
Time Frame
4 months after ARMA
Title
Postinterventional pain
Description
Recording of postinterventional pain in visual analog scale (VAS). Higher scores indicate greater complaints.
Time Frame
1day
Title
Changes in cardia morphology
Description
Changes in Hill's flap grade
Time Frame
4 months after ARMA
Title
Technical success rate
Description
Successful completion of ARMA
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PPI dependent GERD for at least 6 months Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% in pH metry while off PPI Exclusion of primary esophageal motility disorders by manometry Upper endoscopy with biopsy (Exclusion of eosinophilic esophagitis) Exclusion Criteria: Sliding hiatal hernia >3cm Los Angeles grade C/D esophagitis Primary esophageal motility disorders Grade IV Hill´s flap valve Pregnancy or planed pregnancy in the next 12 months Eosinophilic esophagitis Paraesophageal hernia Previous esophageal or gastric surgery Barretts esophagus Liver cirrhosis Varices Lack of consent ASA physical status >III
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdelhafez, MD
Phone
08941409320
Email
Mohamed.Abdelhafez@mri.tum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rami Abbassi, MD
Phone
08941409349
Email
rami.abbassi@mri.tum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelhafez, MD
Organizational Affiliation
Universitiy Hospital Rechts der Isar, Technical Universitiy Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelhafez, MD
Phone
+49894140
Ext
9320
Email
mohamed.abdelhafez@tum.de
First Name & Middle Initial & Last Name & Degree
Rami Abbassi, MD
Phone
08941409349
Email
rami.abbassi@mri.tum.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD

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