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

NCT06339801 | Recruiting FDA Device

• 1 other identifier: HCJSM-24-193
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Evaluate the diagnostic performance of mucosal impedance measurement.
2. 2.Investigate the mucosal impedance pattern in patients with and without GERD.
3. 3.Evaluate the correlation between the global mucosal impedance measurement vs the first 3cm measurement
4. 4.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

Keywords

gastroesophageal reflux; mucosal impedance

Outcome Measures

Primary Outcomes (2)

• diagnostic performance

  diagnostic performance of mucosal impedance measurement

  immediately after the intervention/procedure

• mucosal impedance pattern

  mucosal impedance pattern in patients with and without GERD.

  immediately after the intervention/procedure

Secondary Outcomes (2)

• Correlations

  immediately after the intervention/procedure

• Probability score

  immediately after the intervention/procedure

Study Arms (1)

GERD group

Patients \>18 years presenting symptoms of GERD that have not adequately responded to proton pump inhibitors (PPIs) treatment after 8 weeks and have undergone upper gastrointestinal endoscopy (UGIE) without erosive esophagitis. Patients with a broad spectrum of severity, assessed through the GERDq score, will be included

Device: MiVu

Interventions

MiVu DEVICE

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

GERD group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \>18 years presenting symptoms of GERD that have not adequately responded to proton pump inhibitors (PPIs) treatment after 8 weeks and have undergone upper gastrointestinal endoscopy (UGIE) without erosive esophagitis. Patients with a broad spectrum of severity, assessed through the GERDq score, will be included

You may qualify if:

• Patients \>18 years presenting symptoms of GERD that have not adequately responded to proton pump inhibitors (PPIs) treatment after 8 weeks and have undergone upper gastrointestinal endoscopy (UGIE) without erosive esophagitis.
• Patients with a broad spectrum of severity, assessed through the GERDq score, will be included

You may not qualify if:

• ● Pregnancy or lactation
• Esophageal disorders (esophageal motor disorders, eosinophilic esophagitis, neoplastic diseases)
• Uncontrolled systemic diseases (diabetes mellitus, hypo- or hyperthyroidism, cancer, etc.)
• Lack of informed consent
• Severe psychiatric disorders

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead

Study Sites (1)

Hospital de Clinicas

Buenos Aires, 1119, Argentina

RECRUITING

Related Publications (2)

• Martinez SD, Malagon IB, Garewal HS, Cui H, Fass R. Non-erosive reflux disease (NERD)--acid reflux and symptom patterns. Aliment Pharmacol Ther. 2003 Feb 15;17(4):537-45. doi: 10.1046/j.1365-2036.2003.01423.x.

  PMID: 12622762 BACKGROUND

• Gyawali CP, Yadlapati R, Fass R, Katzka D, Pandolfino J, Savarino E, Sifrim D, Spechler S, Zerbib F, Fox MR, Bhatia S, de Bortoli N, Cho YK, Cisternas D, Chen CL, Cock C, Hani A, Remes Troche JM, Xiao Y, Vaezi MF, Roman S. Updates to the modern diagnosis of GERD: Lyon consensus 2.0. Gut. 2024 Jan 5;73(2):361-371. doi: 10.1136/gutjnl-2023-330616.

  PMID: 37734911 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Officials

• JORGE A OLMOS, MD

  HOSPITAL DE CLINICAS JOSE DE SAN MARTIN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIA M PISKORZ, MD

CONTACT

5491133192885; neurogastrohc@gmail.com

JORGE A OLMOS, MD

CONTACT

5491154128577; jorge.a.olmos@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 1, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

AR (1)