Measuring mucosal impedance to diagnose gastroesophageal reflux disease
Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease
This study is testing a new way to measure the lining of the esophagus to see if it can help diagnose gastroesophageal reflux disease (GERD) better in patients who haven't improved with standard medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospital de Clinicas José de San Martín Academic / other |
| Locations | 1 site (Buenos Aires) |
| Trial ID | NCT06339801 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the role of mucosal impedance measurement in diagnosing gastroesophageal reflux disease (GERD), particularly in patients who have not responded adequately to proton pump inhibitors. It addresses the limitations of current diagnostic methods, such as upper gastrointestinal endoscopy and 24-hour impedance-pH monitoring, which may not provide sufficient sensitivity or specificity. By utilizing a minimally invasive device, the study seeks to improve diagnostic accuracy for patients with Non-Erosive Reflux Disease (NERD) and enhance treatment strategies based on accurate diagnoses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who exhibit GERD symptoms that have not improved with proton pump inhibitors and have normal endoscopic findings.
Not a fit: Patients with esophageal disorders, uncontrolled systemic diseases, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of GERD, allowing for better-targeted treatments and improved patient outcomes.
How similar studies have performed: While the use of mucosal impedance measurement is a relatively novel approach, existing studies have indicated potential benefits in improving GERD diagnosis, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * ● 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
Where this trial is running
Buenos Aires
- Hospital de Clinicas — Buenos Aires, Argentina (Recruiting)
Study contacts
- Principal investigator: Jorge a Olmos, Md — Hospital de Clinicas Jose de San Martin
- Study coordinator: Maria M Piskorz, Md
- Email: neurogastrohc@gmail.com
- Phone: 5491133192885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.