Non-erosive reflux disease (NERD)--acid reflux and symptom patterns.
S D Martinez, I B Malagon, H S Garewal...
https://pubmed.ncbi.nlm.nih.gov/12622762Actively Recruiting
Age: 18Years - 65Years
All Genders
ID06339801
Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease
Led by Hospital de Clinicas José de San Martín · Updated on 2025-01-03
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
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 MiVu 20Mucosal Integrity Testing System. This device attaches to the endoscope and measures esophageal tissue changes linked to reflux. Afterward, participants will have 24-hour impedance/pH 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
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years with GERD symptoms not adequately responding to proton pump inhibitors after at least 8 weeks
- Patients who have undergone upper gastrointestinal endoscopy without erosive esophagitis
- Patients with a range of symptom severity assessed by GERDq score
You will not qualify if you...
- Pregnancy or lactation
- Esophageal disorders such as motor disorders, eosinophilic esophagitis, or neoplastic diseases
- Uncontrolled systemic diseases including diabetes, thyroid disorders, or cancer
- Lack of informed consent
- Severe psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline measurements and PPI washout instructions
Implementation
Duration - 1 day
Participants undergo mucosal impedance measurement during an upper gastrointestinal endoscopy under sedation, followed by 24-hour impedance/pH monitoring without proton pump inhibitors.
1 visit (in-person) for endoscopy and mucosal impedance measurement and subsequent 24-hour monitoring
Monitoring
Duration - 8 weeks
Participants are monitored for 8 weeks while receiving treatment based on their diagnostic categorization, followed by a GerdQ symptom assessment.
1 follow-up visit for symptom assessment after treatment
Trial Site Locations
Total: 1 location
1
Hospital de Clinicas
Buenos Aires, Argentina, 1119
Actively Recruiting
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Research Team
M
MARIA M PISKORZ, MD
J
JORGE A OLMOS, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Updates to the modern diagnosis of GERD: Lyon consensus 2.0.
C Prakash Gyawali, Rena Yadlapati, Ronnie Fass...
https://pubmed.ncbi.nlm.nih.gov/37734911