Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD

NCT05763485 | Unknown

• 1 other identifier: R0001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

anti reflux mucosal ablation; ARMA

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Secondary Outcomes (11)

• Change in symptoms of gastro esophageal reflux disease

  12 months

• Change in symptoms of gastro esophageal reflux disease

  12 months

• Change in symptoms of gastro esophageal reflux disease

  12 months

• Change in symptoms of gastro esophageal reflux disease

  12 months

• Complication rate

  12 months

Study Arms (2)

Anti reflux mucosal ablation (ARMA)

ACTIVE COMPARATOR

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.

Procedure: Anti reflux mucosal ablation (ARMA)

Sham procedure

SHAM COMPARATOR

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.

Procedure: Sham procedure

Interventions

Anti reflux mucosal ablation (ARMA) PROCEDURE

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.

Anti reflux mucosal ablation (ARMA)

Sham procedure PROCEDURE

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.

Sham procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mohamed Abdelhafez, MD

  Universitiy Hospital Rechts der Isar, Technical Universitiy Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Abdelhafez, MD

CONTACT

08941409320; Mohamed.Abdelhafez@mri.tum.de

Rami Abbassi, MD

CONTACT

08941409349; rami.abbassi@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are randomized equally into an intervention and control group. The patients remain blinded to the procedure until 4 months after the initial procedure.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr. Abdelhafez

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 10, 2023
• Study Start: March 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)