Role of ARMA in Selective Subset of Refractory GERD Patients.

Status Recruiting

Clinical Trial 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05899491
Study type	Interventional
Source	Asian Institute of Gastroenterology, India
Contact	Neeraj Singla, MD, DM
Phone	8669188042
Email	docneersk@gmail.com
Status	Recruiting
Phase	N/A
Start date	March 30, 2023
Completion date	December 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06084572` - Prospective Evaluation of pH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
Completed	`NCT03568825` - Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose	N/A
Recruiting	`NCT04703374` - A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects	Phase 1
Completed	`NCT04120025` - Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients	N/A
Withdrawn	`NCT04771247` - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy	N/A
Completed	`NCT02575287` - Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes	N/A
Completed	`NCT01710800` - Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy	N/A
Completed	`NCT00287339` - The Utility of Nexium in Chronic Cough and Reflux Disease	Phase 4
Completed	`NCT00287391` - Sleep Disorders and Gastroesophageal Reflux Disease (GERD)	Phase 4
Completed	`NCT00629564` - An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)	Phase 4
Completed	`NCT04243668` - ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)	N/A
Completed	`NCT03558477` - PK/PD Clinical Trial of YYD601 in Healthy Adult Male	Phase 1
Recruiting	`NCT05042063` - Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
Completed	`NCT05069493` - Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Completed	`NCT03238534` - Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS	Phase 4
Recruiting	`NCT05974722` - Mesh Vs Pledgets for Repair of Paraesophageal Hernia	N/A
Recruiting	`NCT05781347` - Stretta Versus Conservative Treatment in Obese and Non-obese	N/A
Completed	`NCT06141577` - A Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of UI059 and UIC202201 in Healthy Subjects	Phase 1
Recruiting	`NCT05108038` - A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects	Phase 1
Recruiting	`NCT02587910` - Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease	Phase 2/Phase 3