ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease

NCT05425771 | Unknown

• 1 other identifier: ARMA01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study of the possible clinical response to anti reflux mucosal ablation in patients with chronic refractory reflux disease

Conditions

Gastro-esophageal Reflux; Reflux, Gastroesophageal

Keywords

Reflux disease; Endoscopic therapy

Outcome Measures

Primary Outcomes (2)

• change of GERD-HRQL

  The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) is a standardized questionaire and a quantitative method of measuring symptom severity in gastroesophageal reflux disease (GERD). The results are from minimal 0 points up to 50 points. The higher the points, the greater the complaints.

  Before and after 2 and 6 Month

• Rate of major complications

  Recording of all major complication which require hospitalization

  day 1

Secondary Outcomes (3)

• Technical success nominal scale

  Day 1

• change of DeMeester Score

  Before and after 2 and 6 Month

• change of reflux events

  Before and after 2 and 6 Month

Study Arms (1)

Mucosa Ablation Arm

EXPERIMENTAL

Treatment group

Procedure: Anti Reflux Mucosa Ablation

Interventions

Anti Reflux Mucosa Ablation PROCEDURE

Mucosa ablation with Argon plasma coagulation performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm in patients with refractory reflux symptoms

Mucosa Ablation Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• typical reflux symptoms more than 2x per week during PPI therapy more than 6 month
• proof of gastro-esophageal reflux in pH metry oder pH/Impedance measurement

You may not qualify if:

• age \< 18 y
• primary motility disorder of the esophagus
• hiatal hernia \> 3 cm
• Hill classification \> III
• pregnancy
• coagulation disorder
• mandatory intake of oral anticoagulation drugs

Sponsors & Collaborators

• Klinikum Garmisch-Patenkirchen: lead

Study Sites (1)

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, Bavaria, 82467, Germany

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study of mucosal ablation for therapy refractory reflux disease

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: June 21, 2022
• Study Start: July 14, 2022
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)