Role of ARMA in Selective Subset of Refractory GERD Patients.

Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.

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

Study Overview

• Status: Completed
• Conditions: GERD; Reflux; Reflux Esophagitis
• Intervention / Treatment: Procedure: ARMA; Procedure: UGI Endoscopy

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • Asian institute of Gastroenterology, hyderabad, India

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in esophageal acid exposure	Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.	One Year

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Neeraj Singla, MD, Asian Institute of Gastroenterology, Hyderabad; Study Chair: Digvijay Chavan, Asian Institute of Gastroenterology, Hyderabad

Publications and helpful links

General Publications

• Inoue H, Tanabe M, de Santiago ER, Abad MRA, Shimamura Y, Fujiyoshi Y, Ueno A, Sumi K, Tomida H, Iwaya Y, Ikeda H, Onimaru M. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open. 2020 Feb;8(2):E133-E138. doi: 10.1055/a-1031-9436. Epub 2020 Jan 22.
• Chou CK, Chen CC, Chen CC, Wu JF, Liao WC, Chiu HM, Wang HP, Wu MS, Tseng PH. Positive and negative impact of anti-reflux mucosal intervention on gastroesophageal reflux disease. Surg Endosc. 2023 Feb;37(2):1060-1069. doi: 10.1007/s00464-022-09605-z. Epub 2022 Sep 15.
• Rodriguez de Santiago E, Albeniz E, Estremera-Arevalo F, Teruel Sanchez-Vegazo C, Lorenzo-Zuniga V. Endoscopic anti-reflux therapy for gastroesophageal reflux disease. World J Gastroenterol. 2021 Oct 21;27(39):6601-6614. doi: 10.3748/wjg.v27.i39.6601.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: April 1, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophageal Diseases; Gastroenteritis; Duodenal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Peptic Ulcer; Esophagitis; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: ARMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No