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NCT02114606 · ClinicalTrials.gov registry record · NA

Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge

A NA study, sponsored by University of North Carolina, Chapel Hill.

Terminated
Registry status
NA
Development phase
86
Enrollment target

NCT02114606: Clinical Trial NA study, sponsored by University of North Carolina, Chapel Hill.

NCT02114606 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 86 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02114606, a NA study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.

TERMINATED
Registry status
NA
Development phase
86 participants
Enrollment target

Study Summary

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.

Primary Outcome

The primary outcome variables are sensitivity (percent agreement between positive results) and specificity (percent agreement between negative results) of the Cytosponge ability to detect the presence of EoE as compared to upper endoscopy with biopsy (the gold standard for diagnosis and monitoring of EoE). Overall agreement is defined as percentage of Cytosponge procedures yielding results consistent with endoscopic biopsy results. Presence of EoE is measured by the count of eosinophils present

Interventions

  • DEVICE Cytosponge™ Cell Collection Device

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2015-07
Est. Completion 2016-06
Phase NA

Why NCT02114606 stopped before completion

NCT02114606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Cytosponge™ Cell Collection Device is the first listed.

NCT02114606 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02114606 about?

NCT02114606 is a clinical study titled "Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge". 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'...

What is the current status of trial NCT02114606?

This trial is currently terminated. It is a NA study. The enrollment target is 86 participants. The study started on 2015-07. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02114606?

The interventions under investigation include: Cytosponge™ Cell Collection Device (DEVICE).

Who is sponsoring clinical trial NCT02114606?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02114606's enrollment target sits among peer trials

86 976th of 2000 higher than 1,021 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02114606, the US trial registry maintained by the National Library of Medicine. NCT02114606 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.