About this trial
Background \& Significance Chronic benign esophageal disorders such as Gastroesophageal reflux disease (GERD) and eosinophilic esophagitis are common gastrointestinal disorders affecting nearly 20% and 0.1% of the population, respectively. Although these conditions are frequent, the diagnosis of GERD or EoE requires complex decision making involving endoscopic examination, histopathological examination, and esophageal pH testing. This translates into significant economic burden; For example, burden due to GERD is about $24 billion annually. Additionally, there may be a delay in the diagnosis of GERD or EoE as Investigators might have to do multiple procedures such as upper endoscopy, esophageal pH testing, etc for the same participant for confirmation of the diagnosis. In addition, there could be overlay between GERD and EoE in the diagnosis which make cause delay in the diagnosis and decision making.
Aim:
Here, Investigators will plan to identify the diagnostic utility and cost-effectiveness of this novel Mivu device(FDA approved) in the diagnosis of gastroesophageal reflux disease or chronic esophageal inflammatory disorders in participants with reflux symptoms or chronic esophageal symptoms.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Presence of esophageal stricture
Unstable patients who cannot undergo this testing.
Patients on anticoagulation on the day of procedure.
Presence of esophageal cancer.
Trial population
All the patients with reflux symptoms or dysphagia/esophageal symptoms who undergo upper endoscopy will be enrolled into the study.
Trial design
Case-only
Prospective
Treatments tested in this trial
MuVI Esophageal mucosal impedance testing
DeviceEsophageal mucosal impedance values are checked in both groups
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy of MuVI
Sensitivity and Specificity of MuVI
Diagnostic utility of mucosal impedance in the diagnosis of GERD
Correlation of esophageal pH parameters with mucosal impedance data.
Sponsors and contacts
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