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 — DEVICEEsophageal 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 GERDPositive endoscopy findings or esophageal pH results based on Lyon 2.0
- Arm: Functional HeartburnNegative endoscopy and negative esophageal pH testing results
Primary Outcome Measure
Diagnostic accuracy of MuVI [ Time Frame: 1 year ]
Central Contacts
- Gokulakrishnan Balasubramanian414-805-3827
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 |
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