Eosinophilic EsophagitisNCT02114606
Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge
A study testing Cytosponge™ Cell Collection Device in people with Eosinophilic Esophagitis and EoE, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Eosinophilic Esophagitis, EoE
- What is being tested?
- Cytosponge™ Cell Collection Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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).
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
Mayo Clinic
Rochester, Minnesota, 55902
About this study
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.
Read the detailed description
Study design overview (all Aims) This will be a prospective cohort study, with patient enrollment conducted at UNC and Mayo Clinic with sample analysis performed by the University of Cambridge. In Aim 1, patients with EoE will be enrolled, tissue will be obtained from both the Cytosponge and endoscopy, and the methods will be compared for a single time point to determine accuracy of Cytosponge for quantifying esophageal eosinophil counts. For all patients, safety will be monitored and subjects will complete a survey about the acceptability of Cytosponge (Aim 2).
Cytosponge protocol:
After the study has been explained and a patient provides informed consent, the Cytosponge will be administered prior to endoscopy by trained research staff under physician supervision. If subjects opt to receive a local anesthetic, then they will be provided with a 2% lidocaine gargle prior to administration of the Cytosponge. The Cytosponge will be administered according to it's instructions for use. After retrieval, the string is cut and the sponge (which contains the tissue specimen) is placed in a container, immersed in fixative, and stored in a refrigerator at 4°C. The fixative is then spun in a centrifuge, and the pelleted cells are embedded in a paraffin block using standard techniques.
Upper endoscopy and biopsy:
After the Cytosponge has been removed, the patient will undergo standard of care (routine care) upper endoscopy and biopsy, as clinically indicated. During this exam, research staff will record all endoscopic features of EoE, including rings, furrows, white plaques, decreased vascularity, and strictures. The severity of the endoscopy findings will be measured using the recently validated endoscopic reference score (EREFS) scoring system. Four esophageal biopsies will be taken both from the distal (5 cm above the gastro-esophageal junction) and proximal (15 cm above the gastro-esophageal junction) esophagus. This number of biopsies has been shown to maximize the diagnostic sensitivity for EoE.
Histology and eosinophil counts:
All tissue samples from the Cytosponge and endoscopy will be coded with a subject's identification number, but will otherwise be masked for all clinical data, including EoE activity, symptoms, patient characteristics, and treatments prescribed. Using the paraffin blocks, pathology slides will be cut and the tissue processed with routine H\&E staining. The slides will then be digitized, and using the Aperio ImageScope (Aperio Technologies, Vista, CA), the maximum eosinophil density (eosinophils/mm2 [eos/mm2]) will be determined using our previously validated protocol. For purposes of comparison to previous studies, eosinophil density will then be converted to eosinophil counts (eos/hpf) for an assumed hpf size of 0.24 mm2, the size of an average field as reported in the literature. The study pathologists from UNC and Mayo Clinic will review the specimens from their sites, and the study pathology from Cambridge will provide a second review of all specimens to ensure the most accurate quantification of eosinophil counts possible.
In addition, investigators plan to perform special staining and analysis of the existing biopsy and sponge samples with the goal of determining if the diagnostic accuracy of this test can be improved. In particular investigators will examine markers of eosinophil function, activation, and inflammation, such as eosinophil peroxidase (EPX), a granule protein that clearly identifies intact eosinophils, as well as extracellular EPX deposition suggestive of degranulation. This can be detected with immunohistochemistry. This would be done at Mayo clinic with our current collaborators who currently have the coded specimens.
Safety and accessibility assessments:
Patients will be assessed at multiple points to determine the safety of the Cytosponge in EoE. Investigators will assess for any symptoms or events as soon as the sponge capsule is swallowed, as well as immediately after the expanded sponge is removed. Participants will be contacted 1 and 7 days after the endoscopy to assess for adverse events. For Aim 2, participants will be administered the acceptability survey at the 7 day follow-up point, so patients have adequate time to reflect on their experiences with both tissue collection approaches. In particular this survey will record the patient's experience with swallowing the Cytosponge, whether they would do it again, and whether they prefer the Cytosponge or endoscopy for diagnosis and monitoring of EoE.
- Conditions
- Eosinophilic Esophagitis, EoE
- Being tested
- Cytosponge™ Cell Collection Device
- Keywords
- Eosinophilic Esophagitis, EoE, Cytosponge
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytosponge™ Cell Collection DeviceDevice
Also called Cytosponge
The Cytosponge™ Cell Collection Device (Cytosponge) is intended to collect surface cells from the esophagus. The device consists of a swallowable capsule, which dissolves in the body cavity, releasing a self-expandable sponge. The sponge is then retrieved from the esophagus using an attached cord. During the retrieval process, the sponge collects cells from the most superficial layer of the esophageal mucosa. Once removed from the body cavity, the sponge and cells are retained for investigation and/or testing. The Cytosponge™ Cell Collection Device (Cytosponge) received 510(k) clearance from the FDA on November 26, 2014 (K142695). The Cytosponge ™ Cell Collection device is a Class II product under 21 CFR 874.4710 esophagoscope (flexible or rigid) and accessories.
| Study group | Role | What they receive |
|---|---|---|
| EoE Patients | Experimental | Patients who have been diagnosed with EoE as per recent guidelines will be enrolled. Samples will be obtained using the Cytosponge™ Cell Collection Device (Cytosponge) prior to participants' routine endoscopy with biopsy. Receives: Device: Cytosponge™ Cell Collection Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Agreement Between Cytosponge and Endoscopic Biopsy Results
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 per high power field (eos/HPF) with active EoE defined as >=15 eos/HPF.
Sensitivity was calculated via percentage of positive (active EoE) results obtained via Cytosponge as compared to results indicating active EoE via endoscopy with biopsy.
Specificity was calculated via percentage of negative (inactive EoE) results obtained via Cytosponge as compared to results indicating inactive EoE via endoscopy with biopsy.
Measured: At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment
Secondary outcomes (3)
Overall Agreement Between Cytosponge and Endoscopic Biopsy Results as Measured by Kappa
Overall agreement (Cytosponge procedures yielding results consistent with endoscopic biopsy results) as measured by Cohen's Kappa. Overall Cohen's Kappa is a statistical measure for assessing the reliability of agreement between the two results by taking into account the element of chance. Cohen's kappa can range from 0 to 1 with 1 indicating perfect agreement and 0 indicating an agreement equivalent to chance.
Measured: At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment
Acceptability of Cytosponge Compared to Endoscopic Biopsy, as Measured by Visual Analog Scale
Acceptability of Cytosponge compared to endoscopic biopsy as measured by visual analogue scale. Participants were asked to rate their experience of the procedures on a scale of 0-10, where 0 indicates "unacceptable, very difficult even for a medical test," and 10 indicates "not an issue, would take test." A higher score indicates a more acceptable test. Acceptability was measured after each procedure and scores from each assessment were summed to obtain the mean and standard deviation.
Measured: 7 days after each procedure
Acceptability of Cytosponge as Measured by the Impact of Events Scale
Acceptability of Cytosponge as measured by the Impact of Events (IES) scale. The IES measures subjective distress (such as intrusive thoughts or emotions and avoidant or anxious behavior) following a stressful event. Respondents are asked to answer questions to indicate the amount of stress from the event.
Scores are calculated using the following scale: Not at all =0, Rarely =1, Sometimes =3, Often =4. The total score is calculated by adding each response, with a total final score ranging from (0-60). Scores ranging 0-8 indicate no meaningful impact, scores ranging 9-25 indicate impact, and scores of 26 and above are considered very important (26-43 = powerful impact, 44-75 = severe impact).
Acceptability was measured after each procedure and scores from each assessment were summed to obtain the mean and standard deviation.
Measured: 7 days after each procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Cytosponge device availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, University of Cambridge, CURED Foundation
- Responsible party
- Sponsor
- Investigators
- Evan Dellon, MD, MPH, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114606
- Sponsor's protocol ID
- 13-3521
- Status last verified
- Nov 2020
- First submitted
- 8 Apr 2014
- Last updated
- 17 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hirano I, Moy N, Heckman MG, Thomas CS, Gonsalves N, Achem SR. Endoscopic assessment of the oesophageal features of eosinophilic oesophagitis: validation of a novel classification and grading system. Gut. 2013 Apr;62(4):489-95. doi: 10.1136/gutjnl-2011-301817. Epub 2012 May 22.
PubMed 22619364Gonsalves N, Policarpio-Nicolas M, Zhang Q, Rao MS, Hirano I. Histopathologic variability and endoscopic correlates in adults with eosinophilic esophagitis. Gastrointest Endosc. 2006 Sep;64(3):313-9. doi: 10.1016/j.gie.2006.04.037.
PubMed 16923475Dellon ES, Fritchie KJ, Rubinas TC, Woosley JT, Shaheen NJ. Inter- and intraobserver reliability and validation of a new method for determination of eosinophil counts in patients with esophageal eosinophilia. Dig Dis Sci. 2010 Jul;55(7):1940-9. doi: 10.1007/s10620-009-1005-z. Epub 2009 Oct 15.
PubMed 19830560Dellon ES, Aderoju A, Woosley JT, Sandler RS, Shaheen NJ. Variability in diagnostic criteria for eosinophilic esophagitis: a systematic review. Am J Gastroenterol. 2007 Oct;102(10):2300-13. doi: 10.1111/j.1572-0241.2007.01396.x. Epub 2007 Jul 7.
PubMed 17617209Katzka DA, Smyrk TC, Alexander JA, Geno DM, Beitia RA, Chang AO, Shaheen NJ, Fitzgerald RC, Dellon ES. Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study. Am J Gastroenterol. 2017 Oct;112(10):1538-1544. doi: 10.1038/ajg.2017.244. Epub 2017 Aug 15.
PubMed 28809387
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge
- ClinicalTrials.gov ID
- NCT02114606
- Acronym / sponsor ID
- 13-3521
- Conditions
- Eosinophilic Esophagitis, EoE
- Keywords
- Eosinophilic Esophagitis, EoE, Cytosponge
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cytosponge device availability
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Mayo Clinic, University of Cambridge, CURED Foundation
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Posted 17 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design overview (all Aims) This will be a prospective cohort study, with patient enrollment conducted at UNC and Mayo Clinic with sample analysis performed by the University of Cambridge. In Aim 1, patients with EoE will be enrolled, tissue will be obtained from both the Cytosponge and endoscopy, and the methods will be compared for a single time point to determine accuracy of Cytosponge for quantifying esophageal eosinophil counts. For all patients, safety will be monitored and subjects will complete a survey about the acceptability of Cytosponge (Aim 2).
Cytosponge protocol:
After the study has been explained and a patient provides informed consent, the Cytosponge will be administered prior to endoscopy by trained research staff under physician supervision. If subjects opt to receive a local anesthetic, then they will be provided with a 2% lidocaine gargle prior to administration of the Cytosponge. The Cytosponge will be administered according to it's instructions for use. After retrieval, the string is cut and the sponge (which contains the tissue specimen) is placed in a container, immersed in fixative, and stored in a refrigerator at 4°C. The fixative is then spun in a centrifuge, and the pelleted cells are embedded in a paraffin block using standard techniques.
Upper endoscopy and biopsy:
After the Cytosponge has been removed, the patient will undergo standard of care (routine care) upper endoscopy and biopsy, as clinically indicated. During this exam, research staff will record all endoscopic features of EoE, including rings, furrows, white plaques, decreased vascularity, and strictures. The severity of the endoscopy findings will be measured using the recently validated endoscopic reference score (EREFS) scoring system. Four esophageal biopsies will be taken both from the distal (5 cm above the gastro-esophageal junction) and proximal (15 cm above the gastro-esophageal junction) esophagus. This number of biopsies has been shown to maximize the diagnostic sensitivity for EoE.
Histology and eosinophil counts:
All tissue samples from the Cytosponge and endoscopy will be coded with a subject's identification number, but will otherwise be masked for all clinical data, including EoE activity, symptoms, patient characteristics, and treatments prescribed. Using the paraffin blocks, pathology slides will be cut and the tissue processed with routine H\&E staining. The slides will then be digitized, and using the Aperio ImageScope (Aperio Technologies, Vista, CA), the maximum eosinophil density (eosinophils/mm2 [eos/mm2]) will be determined using our previously validated protocol. For purposes of comparison to previous studies, eosinophil density will then be converted to eosinophil counts (eos/hpf) for an assumed hpf size of 0.24 mm2, the size of an average field as reported in the literature. The study pathologists from UNC and Mayo Clinic will review the specimens from their sites, and the study pathology from Cambridge will provide a second review of all specimens to ensure the most accurate quantification of eosinophil counts possible.
In addition, investigators plan to perform special staining and analysis of the existing biopsy and sponge samples with the goal of determining if the diagnostic accuracy of this test can be improved. In particular investigators will examine markers of eosinophil function, activation, and inflammation, such as eosinophil peroxidase (EPX), a granule protein that clearly identifies intact eosinophils, as well as extracellular EPX deposition suggestive of degranulation. This can be detected with immunohistochemistry. This would be done at Mayo clinic with our current collaborators who currently have the coded specimens.
Safety and accessibility assessments:
Patients will be assessed at multiple points to determine the safety of the Cytosponge in EoE. Investigators will assess for any symptoms or events as soon as the sponge capsule is swallowed, as well as immediately after the expanded sponge is removed. Participants will be contacted 1 and 7 days after the endoscopy to assess for adverse events. For Aim 2, participants will be administered the acceptability survey at the 7 day follow-up point, so patients have adequate time to reflect on their experiences with both tissue collection approaches. In particular this survey will record the patient's experience with swallowing the Cytosponge, whether they would do it again, and whether they prefer the Cytosponge or endoscopy for diagnosis and monitoring of EoE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EoE Patients | Experimental | Device: Cytosponge™ Cell Collection DevicePatients who have been diagnosed with EoE as per recent guidelines will be enrolled. Samples will be obtained using the Cytosponge™ Cell Collection Device (Cytosponge) prior to participants' routine endoscopy with biopsy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytosponge™ Cell Collection DeviceAlso: CytospongeThe Cytosponge™ Cell Collection Device (Cytosponge) is intended to collect surface cells from the esophagus. The device consists of a swallowable capsule, which dissolves in the body cavity, releasing a self-expandable sponge. The sponge is then retrieved from the esophagus using an attached cord. During the retrieval process, the sponge collects cells from the most superficial layer of the esophageal mucosa. Once removed from the body cavity, the sponge and cells are retained for investigation and/or testing. The Cytosponge™ Cell Collection Device (Cytosponge) received 510(k) clearance from the FDA on November 26, 2014 (K142695). The Cytosponge ™ Cell Collection device is a Class II product under 21 CFR 874.4710 esophagoscope (flexible or rigid) and accessories. | Device | EoE Patients |
Primary outcome
Percent Agreement Between Cytosponge and Endoscopic Biopsy Results
Time frame: At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment
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 per high power field (eos/HPF) with active EoE defined as >=15 eos/HPF. Sensitivity was calculated via percentage of positive (active EoE) results obtained via Cytosponge as compared to results indicating active EoE via endoscopy with biopsy. Specificity was calculated via percentage of negative (inactive EoE) results obtained via Cytosponge as compared to results indicating inactive EoE via endoscopy with biopsy.
3 secondary outcomes
Overall Agreement Between Cytosponge and Endoscopic Biopsy Results as Measured by Kappa
Time frame: At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment
Acceptability of Cytosponge Compared to Endoscopic Biopsy, as Measured by Visual Analog Scale
Time frame: 7 days after each procedure
Acceptability of Cytosponge as Measured by the Impact of Events Scale
Time frame: 7 days after each procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22619364Hirano I, Moy N, Heckman MG, Thomas CS, Gonsalves N, Achem SR. Endoscopic assessment of the oesophageal features of eosinophilic oesophagitis: validation of a novel classification and grading system. Gut. 2013 Apr;62(4):489-95. doi: 10.1136/gutjnl-2011-301817. Epub 2012 May 22.
- Background: PubMed 16923475Gonsalves N, Policarpio-Nicolas M, Zhang Q, Rao MS, Hirano I. Histopathologic variability and endoscopic correlates in adults with eosinophilic esophagitis. Gastrointest Endosc. 2006 Sep;64(3):313-9. doi: 10.1016/j.gie.2006.04.037.
- Background: PubMed 19830560Dellon ES, Fritchie KJ, Rubinas TC, Woosley JT, Shaheen NJ. Inter- and intraobserver reliability and validation of a new method for determination of eosinophil counts in patients with esophageal eosinophilia. Dig Dis Sci. 2010 Jul;55(7):1940-9. doi: 10.1007/s10620-009-1005-z. Epub 2009 Oct 15.
- Background: PubMed 17617209Dellon ES, Aderoju A, Woosley JT, Sandler RS, Shaheen NJ. Variability in diagnostic criteria for eosinophilic esophagitis: a systematic review. Am J Gastroenterol. 2007 Oct;102(10):2300-13. doi: 10.1111/j.1572-0241.2007.01396.x. Epub 2007 Jul 7.
- Results publication: PubMed 28809387Katzka DA, Smyrk TC, Alexander JA, Geno DM, Beitia RA, Chang AO, Shaheen NJ, Fitzgerald RC, Dellon ES. Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study. Am J Gastroenterol. 2017 Oct;112(10):1538-1544. doi: 10.1038/ajg.2017.244. Epub 2017 Aug 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Dellon, MD, MPH principal investigator
UNC-Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosponge™ Cell Collection Device in people with Eosinophilic Esophagitis and EoE, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Agreement Between Cytosponge and Endoscopic Biopsy Results (time frame: At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114606, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.