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History of Changes for Study: NCT05425771
ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease (ARMA)
Latest version (submitted July 13, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 15, 2022 None (earliest Version on record)
2 July 13, 2022 Study Status
Comparison Format:

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Study NCT05425771
Submitted Date:  June 15, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: ARMA01
Brief Title: ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease (ARMA)
Official Title: ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2022
Overall Status: Not yet recruiting
Study Start: June 15, 2022
Primary Completion: December 31, 2022 [Anticipated]
Study Completion: May 31, 2023 [Anticipated]
First Submitted: January 28, 2022
First Submitted that
Met QC Criteria:
June 15, 2022
First Posted: June 21, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
June 15, 2022
Last Update Posted: June 21, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Klinikum Garmisch-Patenkirchen
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Pilot study of the possible clinical response to anti reflux mucosal ablation in patients with chronic refractory reflux disease
Detailed Description:

Prospective, non-controlled, monocentric pilot study in patients with therapy-refractory reflux symptoms under proton pump inhibitor (PPI) therapy or intolerance of the necessary therapy or rapid recurrence of the symptoms with tapering therapy.

The symptoms must have existed for >6 months. Gastroesophageal reflux disease (GERD) must be diagnosed before inclusion in the study. This is the case if either erosive reflux esophagitis according to Los Angeles classification grades A-D is present or non-erosive reflux disease (NERD) has been confirmed by a 24-hour pH measurement/impedance measurement. The measurement must show either an increased number of reflux events or a prolonged time under reflux. In addition, there must be a high correlation between symptoms and reflux events when reporting symptom events. The GERD-HRQL score is queried for the clinical quantification of symptoms.

An esophageal motility disorder, especially achalasia or relevant hypomotility must be ruled out in an high resolution esophageal manometry. A relevant gastric emptying disorder is ruled out using a C13 octanoate breath test.

Patients with a Hill IV axial hernia, a paraesophageal hernia, or Barrett's esophagus are not included. Pregnancy must be ruled out in women of childbearing age.

The ARMA procedure is explained to the patient in detail with the expected benefits and risks in oral and written form. In addition, alternative treatments such as surgical fundoplication are discussed.

In the ARMA procedure, a gastroscopy is performed under sedation with propofol. Argon plasma coagulation (APC) is performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm, as described in the original publication. The intended destruction of the uppermost layer of the gastroesophageal junction is intended to induce an inflammatory reaction with subsequent shrinkage of the corresponding tissue section. This leads to a tightening of the gastroesophageal junction with subsequent improved tightness, so that reflux events occur less frequently.

Patients will be monitored in hospital for 48 hours. The existing drug therapy is continued for 4 weeks and then tapered off.

Endoscopic and clinical follow-up checks take place after 2 and 6 months using gastroscopy and GERD-HRQL score.

Open or close this module Conditions
Conditions: Gastro-esophageal Reflux
Reflux, Gastroesophageal
Keywords: Reflux disease
Endoscopic therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Sequential Assignment
Pilot study of mucosal ablation for therapy refractory reflux disease
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 15 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Mucosa Ablation Arm
Treatment group
Procedure: Anti Reflux Mucosa Ablation
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. change of GERD-HRQL
[ Time Frame: Before and after 2 and 6 Month ]

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.
2. Rate of major complications
[ Time Frame: day 1 ]

Recording of all major complication which require hospitalization
Secondary Outcome Measures:
1. Technical success nominal scale
[ Time Frame: Day 1 ]

In this case, the abortion of the procedure or the subjective assessment of the examiner apply immediately after the end of the procedure.

The examiner evaluates the complete technical success as successful or unsuccessful

2. change of DeMeester Score
[ Time Frame: Before and after 2 and 6 Month ]

The DeMeester score is a scoring system at pH/Impendence measurement that quantifies esophageal acid exposure time in long-term pH monitoring. A DeMeester score of ≤ 14.72 is considered physiological.

The score includes the following values:

Percentage of time with esophageal pH < 4 of total measurement time Percentage of time with pH < 4 during the waking phase (upright position) Percentage of time with pH < 4 during the sleep phase (lying position) Total number of reflux episodes during the measurement time Number of reflux episodes lasting > 5 min Duration of the longest reflux episode

3. change of reflux events
[ Time Frame: Before and after 2 and 6 Month ]

Measurement of the number of events in the pH/Impendence measurement. A count <74 in 24 hours is considered normal.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Open or close this module Contacts/Locations
Locations: Germany, Bayern
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Bayern, Germany, 82467
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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