Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge
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|ClinicalTrials.gov Identifier: NCT02114606|
Recruitment Status : Terminated (Cytosponge device availability)
First Posted : April 15, 2014
Results First Posted : February 17, 2021
Last Update Posted : February 17, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis EoE||Device: Cytosponge™ Cell Collection Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: EoE Patients
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.
Device: Cytosponge™ Cell Collection Device
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.
Other Name: Cytosponge
- 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.
- 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 ]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.
- Acceptability of Cytosponge Compared to Endoscopic Biopsy, as Measured by Visual Analog Scale [ Time Frame: 7 days after each procedure ]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.
- Acceptability of Cytosponge as Measured by the Impact of Events Scale [ Time Frame: 7 days after each procedure ]
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.
- Number of Responses Indicating Preference for Cytosponge Over Endoscopic Biopsy [ Time Frame: 7 days after each procedure ]The number of responses indicating preference for Cytosponge to endoscopic biopsy. Preference was measured by asking participants after each procedure, "which procedure would you prefer to undergo again if your physician indicated it was medically necessary?" with the options "Traditional Upper Endoscopy" and "Cytosponge." The total number of responses recorded as "Cytosponge" and the total number of responses recorded as "Traditional Upper Endoscopy" were summed.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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,
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114606
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27516|
|Principal Investigator:||Evan Dellon, MD, MPH||UNC-Chapel Hill|
Documents provided by University of North Carolina, Chapel Hill:
|Responsible Party:||University of North Carolina, Chapel Hill|
|Other Study ID Numbers:||
|First Posted:||April 15, 2014 Key Record Dates|
|Results First Posted:||February 17, 2021|
|Last Update Posted:||February 17, 2021|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Digestive System Diseases
Immune System Diseases