Role of ARMA in Selective Subset of Refractory GERD Patients.

Last updated: April 2, 2025
Sponsor: Asian Institute of Gastroenterology, India
Overall Status: Completed

Phase

N/A

Condition

Heartburn (Pediatric)

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Treatment

ARMA

UGI Endoscopy

Clinical Study ID

NCT05899491
ARMA
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: ARMA
Phase:
Study Start date:
March 30, 2023
Estimated Completion Date:
December 30, 2023

Study 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.

Connect with a study center

  • Asian institute of Gastroenterology, hyderabad, India

    Hyderabad, Telangana 500032
    India

    Site Not Available

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