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

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ClinicalTrials.gov Identifier: NCT05425771
Recruitment Status : Not yet recruiting
First Posted : June 21, 2022
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
Klinikum Garmisch-Patenkirchen

Tracking Information
First Submitted Date  ICMJE January 28, 2022
First Posted Date  ICMJE June 21, 2022
Last Update Posted Date July 14, 2022
Estimated Study Start Date  ICMJE July 14, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2022)
  • 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.
  • Rate of major complications [ Time Frame: day 1 ]
    Recording of all major complication which require hospitalization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2022)
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease
Official Title  ICMJE ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description:
Pilot study of mucosal ablation for therapy refractory reflux disease
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastro-esophageal Reflux
  • Reflux, Gastroesophageal
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Mucosa Ablation Arm
Treatment group
Intervention: Procedure: Anti Reflux Mucosa Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2022)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05425771
Other Study ID Numbers  ICMJE ARMA01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Klinikum Garmisch-Patenkirchen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Klinikum Garmisch-Patenkirchen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Klinikum Garmisch-Patenkirchen
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP