An interventional study of ARMA and UGI Endoscopy in GERD, Reflux and Reflux Esophagitis, sponsored by Asian Institute of Gastroenterology, India. Completed at 1 site in India. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Treatment
To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Asian Institute of Gastroenterology, India is the lead sponsor of 132 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes.
Procedure: UGI Endoscopy
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.
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.
Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months.
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.
Time frame: One Year
Improvement in esophageal acid exposure
Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.
Time frame: One Year
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Asian Institute of Gastroenterology, India