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Role of ARMA in Selective Subset of Refractory GERD Patients.

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ClinicalTrials.gov Identifier: NCT05899491
Recruitment Status : Recruiting
First Posted : June 12, 2023
Last Update Posted : June 12, 2023
Sponsor:
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India

Study Description
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Brief Summary:
To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).

Condition or disease Intervention/treatment Phase
GERD Reflux Reflux Esophagitis Procedure: ARMA Procedure: UGI Endoscopy Not Applicable

Detailed Description:

Patients coming with symptoms of Gastroesophageal reflux disease (GERD) - A digestive disease in which stomach acid or bile irritates the food pipe lining, will be screened for eligibility and informed written consent will be taken. At initial screening, score based on clinical symptoms i.e. Gastroesophageal Reflux Disease- Quality of Life score (GERD HRQL) & Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease Questionnaire (FSSG) score will be completed. All patients will undergo esophagogastroscopy (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract). to look for reflux (the backward flow of stomach acid into the tube that connects your throat to your stomach (esophagus)) related changes in the esophagus.

Esophageal high-resolution Manometry (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done to measure the various parameters which help doctor understand your disease.

24-hr pH impedance (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done after stopping anti-secretory medicines (medicines for the long-term treatment of GERD) for atleast three days to assess for esophageal parameters.

All patients will be divided randomly into two arms, ARMA and sham. Those in the ARMA arm will receive ARMA procedure, while patients in the sham arm will receive only upper gastrointestinal endoscopy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A Randomized Sham Control Trial
Masking: None (Open Label)
Masking Description: A Randomized Sham Control Trial
Primary Purpose: Treatment
Official Title: Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.
Actual Study Start Date : March 30, 2023
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ARMA Group
All patients in this group will undergo Anti-reflux mucosal ablation using upper gastrointestinal endoscopy. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.
 Procedure: ARMA
Patients will be instructed to fast for 6 hours pre-ARMA, the Procedure will be performed under propofol-based sedation. Patients will be in the left lateral decubitus position. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.
Sham Comparator: Sham Group
UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes.
 Procedure: UGI Endoscopy

UGI Endoscopy will be performed under propofol based sedation with scope kept inside for atleast 5 minutes.

Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry, reflux questionnaire.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months. [ Time Frame: One Year ]
    Improvement in Gastroesophageal reflux disease symptoms by more than 50% from baseline at 3 months which would be assessed based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE.


Secondary Outcome Measures :
  1. Improvement in esophageal acid exposure [ Time Frame: One Year ]
    Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal Upper Gastrointestinal endoscopy And
  • 24 hour pH Impedance: AET < 6%, More than 80 refluxes
  • Patients who are willing to give consent for the procedure

Exclusion Criteria:

  • Large Hiatal hernia >3cm
  • Lower esophageal sphincter (LES) pressure >15 mm Hg
  • Paraesophageal hernia
  • GE flap valve grade IV (Hill's classification)
  • Barretts esophagus
  • Esophageal dysmotility
  • ASA physical status >II
  • Previous esophageal or gastric surgery
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05899491


Contacts
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Contact: Neeraj Singla, MD, DM 8669188042 ext +91 docneersk@gmail.com

Locations
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India
Asian institute of Gastroenterology, hyderabad, India Recruiting
Hyderabad, Telangana, India, 500032
Contact: Neeraj Singla    07013454913    docneersk@gmail.com   
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Principal Investigator: Neeraj Singla, MD Asian Institute of Gastroenterology, Hyderabad
Study Chair: Digvijay Chavan Asian Institute of Gastroenterology, Hyderabad
More Information
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Publications of Results:

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Responsible Party: Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT05899491    
Other Study ID Numbers: ARMA
First Posted: June 12, 2023    Key Record Dates
Last Update Posted: June 12, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases