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/Actively Recruiting
Led by Hospital de Clinicas José de San Martín · Updated on 2025-01-03
100
Participants Needed
1
Research Sites
8 weeks
Total Duration
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
Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease
M
MARIA M PISKORZ, MD
J
JORGE A OLMOS, MD
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Hospital de Clinicas José de San Martín
Lead Sponsor
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Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline measurements and PPI washout instructions
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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C Prakash Gyawali, Rena Yadlapati, Ronnie Fass...
https://pubmed.ncbi.nlm.nih.gov/37734911/S D Martinez, I B Malagon, H S Garewal...
https://pubmed.ncbi.nlm.nih.gov/12622762/Hospital de Clinicas José de San Martín
Lead Sponsor