ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)

NCT04243668 | Completed DMC

• 1 other identifier: ARMA01
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD) DESIGN OF THE Prospective interventional study Sample size: 216

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (3)

• requirement of PPI at 3, 6 and 12 months

  requirement of PPI at 3, 6 and 12 months

• Improvement in esophageal acid exposure

  6 months

• Improvement in lower esophageal sphincter pressure at 3 months

  12 months

Study Arms (1)

ANTI REFLUX MUCOSAL ABLATION THERAPHY

EXPERIMENTAL

In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.

Procedure: ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)

Interventions

ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) PROCEDURE

In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.

ANTI REFLUX MUCOSAL ABLATION THERAPHY

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
• Patients who are willing to pay the expenses of the ARMA procedure

You may not qualify if:

• Large Hiatal hernia \>3cm
• Gr C/D esophagitis
• Lower esophageal sphincter (LES) pressure\<5 or \>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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

Related Publications (1)

• Koduri KK, Singla N, Maragoni RG, Jagtap N, Singh AP, Kalapala R, Reddy DN. Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months. Indian J Gastroenterol. 2025 Oct;44(5):700-707. doi: 10.1007/s12664-025-01761-z. Epub 2025 Jun 11.

  PMID: 40498286 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Nageshwar Reddy, DNB

  Chairman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 28, 2020
• Study Start: September 2, 2019
• Primary Completion: September 2, 2021
• Study Completion: June 30, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)