Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge

Stopped early · Not applicable

Conditions studied: Eosinophilic Esophagitis, EoE

In brief

The current endoscopic methods for diagnosing and monitoring treatment response in Eosinophilic Esophagitis (EoE) are costly, inconvenient, and risky. Novel diagnostic methods are needed, and the minimally-invasive Cytosponge holds great promise. It has been shown to be safe and accurate in Barrett's esophagus, it has the advantage (over the string test) of obtaining a true tissue sample, and our preliminary data supports its further study in EoE. The proposed prospective cohort study, conducted by experts in esophageal diseases and EoE, will assess the accuracy of Cytosponge compared to endoscopy and biopsy in EoE, and determine the safety and acceptability of this technique. Use of the Cytosponge would fundamentally change the paradigm for clinical management of EoE by allowing collection of non-endoscopic esophageal biopsies, thus minimizing the need for invasive testing. It would also facilitate future genetic, mechanistic, and pathogenesis research in EoE.

Key facts

Study ID

NCT02114606

Run by

University of North Carolina, Chapel Hill

People needed

86

Starts

2015-07-01

Expected to finish

2016-06-01

Last updated by the study team

2021-02-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to read, comprehend, and complete the informed consent form
• Male or female subjects, age 18-80 years,
• Suspected EoE or has a diagnoses of EoE with current active disease,

You may not qualify if…

• History of esophageal stricture precluding passage of the endoscope or sponge,
• Pregnancy, or planned pregnancy during the course of the study,
• Any history of esophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B \& C) or evidence of varices noted on any past endoscopy,
• Any history of esophageal surgery, except for uncomplicated fundoplication
• History of coagulopathy, with international normalized ratio (INR) >1.3 and/or platelet count of <75,000.
• Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 7 days prior to and 7 days after esophagogastroduodenoscopy (EGD) and Cytosponge administration, aspirin use is OK).
• Are allergic to local anesthetics such as lidocaine (these subjects may opt not to receive the optional lidocaine gargle prior to the Cytosponge administration and still be eligible).
• Have not fasted the night before administration of the Cytosponge.
• History of perforation

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.