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

NCT06339801 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-01-03

No results posted yet for this study

Summary

Existing current tests for diagnosing GERD are suboptimal because they lack adequate sensitivity or specificity. Upper gastrointestinal endoscopy is highly specific for diagnosing GERD, particularly when erosive esophagitis is present (Los Angeles Classification B, C, or D). Nevertheless, its sensitivity is limited, as this scenario is only present in 30% of cases. Most patients will exhibit normal endoscopic findings, indicating Non-Erosive Reflux Disease (NERD). The 24-hour impedance-pH monitoring (MII) is currently considered the gold standard. However, its main limitation is that it can only measure reflux activity over a 24-hour period, in addition to the discomfort caused by the catheter. 6-8 It is noteworthy that 50% of patients with NERD will have pathological reflux, and the other 50% will have a sensory disorder. The importance of making an accurate diagnosis lies in the treatment, which varies in each case.11 Recently, a minimally invasive device was developed and validated in the USA to assess changes in esophageal mucosal impedance. This serves as a tool for evaluating tissue changes associated with chronic reflux. However, this device has recently undergone improvements. This new technology has not been tested yet for GERD diagnosis. The primary benefit would be the ability to diagnose GERD in symptomatic patients with NERD during the initial endoscopy conducted under sedation.

Objectives

The Main objectives of this study are to:

1. Evaluate the diagnostic performance of mucosal impedance measurement.
2. Investigate the mucosal impedance pattern in patients with and without GERD.

Secondary objectives:

1. Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
2. Evaluate the best probability score to distinguish between GERD and non-GERD Design Prospective, cross-sectional, and analytical study Study Design and Procedures The study will be conducted in the Gastroenterology Department of the Hospital de Clínicas José de San Martin, University of Buenos Aires, Argentina. Following a 4-week screening period during which a proton pump inhibitor (PPI) washout will be performed, and baseline measurements will be taken, all patients will undergo upper gastrointestinal endoscopy with mucosal impedance measurement and 24-hour impedance/pH monitoring.

Conditions

  • Gastroesophageal Reflux

Interventions

DEVICE

MiVu

All patients will undergo mucosal impedance (MI) measurement using the MiVu™ Mucosal Integrity Testing System (Diversatek Healthcare, Inc.).

Sponsors & Collaborators

  • Hospital de Clinicas José de San Martín

    lead OTHER

Principal Investigators

  • JORGE A OLMOS, MD · HOSPITAL DE CLINICAS JOSE DE SAN MARTIN

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2026-06-01
Completion
2026-08-01
FDA Device
Yes

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06339801 on ClinicalTrials.gov