Role of ARMA in Selective Subset of Refractory GERD Patients.

• Sponsor: Asian Institute of Gastroenterology, India (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05899491
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A Randomized Sham Control TrialA 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: Mar 30, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months. [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 [One Year]

   Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Asian institute of Gastroenterology, hyderabad, India	Hyderabad	Telangana	India	500032

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asian Institute of Gastroenterology, India
• ClinicalTrials.gov Identifier: NCT05899491
• Other Study ID Numbers: ARMA
• First Posted: Jun 12, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic

Study Results

No Results Posted as of Jun 12, 2023