Diagnostic Utility of Mucosal Impedance Device in Patients With GERD and Chronic Esophageal Disorders:

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 1\. Patients with chronic esophageal symptoms such as atypical or typical reflux symptoms and dysphagia, is here for upper endoscopy testing.

Locations
United States
Wisconsin
Froedtert Hospital
RECRUITING
Milwaukee
Contact Information
Primary
Gokulakrishnan Balasubramanian
gbalasubramanian@mcw.edu
414-805-3827
Time Frame
Start Date: 2025-11-20
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 50
Treatments
True GERD
Positive endoscopy findings or esophageal pH results based on Lyon 2.0
Functional Heartburn
Negative endoscopy and negative esophageal pH testing results
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov