Utility of Mucosal Impedance Device in Chronic Esophageal Disorders:

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07227506
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • MuVI Esophageal mucosal impedance testing — DEVICE
    Esophageal mucosal impedance values are checked in both groups

Study Details

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.

Key Dates

Start date
Nov 20, 2025
Status verified
Nov 2025
Primary completion
Nov 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: True GERD
    Positive endoscopy findings or esophageal pH results based on Lyon 2.0
  • Arm: Functional Heartburn
    Negative endoscopy and negative esophageal pH testing results

Primary Outcome Measure

Diagnostic accuracy of MuVI [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert HospitalMilwaukeeWisconsin53226
Gokulakrishnan Balasubramanian, MD
414-805-3827

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