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ID06339801

Evaluating Mucosal Impedance Measurement to Diagnose Gastroesophageal Reflux Disease in Adults Aged 18 to 65

Led by Hospital de Clinicas José de San Martín · Updated on 2025-01-03

100

Participants Needed

1

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Gastroesophageal Reflux Disease GERD causes discomfort and complications when stomach contents flow back into the esophagus. Existing tests to diagnose GERD often miss cases or lack accuracy, especially for patients with Non-Erosive Reflux Disease NERD, who show normal endoscopy results but still have symptoms. Researchers aim to evaluate a new mucosal impedance measurement device that may improve diagnosis during initial endoscopy for symptomatic patients with NERD. In this observational study, patients will first stop proton pump inhibitors for four weeks. Then, they will undergo an upper gastrointestinal endoscopy where mucosal impedance is measured using the MiVu20Mucosal Integrity Testing System. This device attaches to the endoscope and measures esophageal tissue changes linked to reflux. Afterward, participants will have 24-hour impedancepH monitoring without proton pump inhibitors, combined with esophageal manometry to locate the lower esophageal sphincter. Patients will be grouped based on acid exposure levels. Participants will be assessed using mucosal impedance patterns and diagnostic performance immediately after procedures. The study also examines correlations and probability scores to distinguish GERD from non-GERD. Treatment responses will be evaluated after eight weeks with follow-up questionnaires. The total involvement includes screening, endoscopy with impedance measurement, 24-hour monitoring, and post-treatment evaluation, all conducted under sedation and medical supervision.

CONDITIONS

Brief Title

Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease

Research Team

M

MARIA M PISKORZ, MD

J

JORGE A OLMOS, MD

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