Recruiting

Mivu Device

Sponsor:

Medical College of Wisconsin

Code:

NCT07227506

Conditions

Gerd

Eosinophilic Esophagitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MuVI Esophageal mucosal impedance testing

Study Details

Brief 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.

Conditions

Gerd

Eosinophilic Esophagitis

Study ID

NCT07227506

Start date

Nov 20, 2025

Status verified date

Jun, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of esophageal stricture
2. Unstable patients who cannot undergo this testing.
3. Patients on anticoagulation on the day of procedure.
4. Presence of esophageal cancer.
5. Pregnancy.
6. Minor patients.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

True GERD

Positive endoscopy findings or esophageal pH results based on Lyon 2.0

Functional Heartburn

Negative endoscopy and negative esophageal pH testing results

Interventions

MuVI Esophageal mucosal impedance testing

Esophageal mucosal impedance values are checked in both groups

Primary outcome measure

  • Diagnostic accuracy of MuVI [ Time Frame: 1 year ]
  • Diagnostic utility of mucosal impedance in the diagnosis of GERD [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Gokulakrishnan Balasubramanian

414-805-3827gbalasubramanian@mcw.edu

Locations

Froedtert Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Gokulakrishnan Balasubramanian, MD

414-805-3827gbalasubramanian@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jul 27, 2026

Last verified

Jun, 2026

Keywords

  • gerd
  • eosinophilic esophagitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-07-27.