Utility of Mucosal Impedance Device in Chronic Esophageal Disorders:

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • MuVI Esophageal mucosal impedance testing

    Device

    Esophageal mucosal impedance values are checked in both groups

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: True GERD1 intervention
Group B: Functional Heartburn1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of MuVI

Sensitivity and Specificity of MuVI

Time frame
1 year
2

Diagnostic utility of mucosal impedance in the diagnosis of GERD

Correlation of esophageal pH parameters with mucosal impedance data.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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