- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01585103
Cytosponge Protocol IRB 11-006429
June 10, 2022 updated by: Jeffrey A Alexander, Mayo Clinic
Cytosponge Protocol
This study is being done to collect data on the potential use of the cytosponge as non-invasive tool in evaluating patients with eosinophilic esophagitis.
Study Overview
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients between the ages of 18 and 65 with eosinophilic esophagitis including lactating or pregnant women undergoing clinically indicated endoscopy and esophageal biopsy.
Exclusion Criteria:
- Patients for whom clinically indicated endoscopy is not safe. Patients who have small caliber esophagus, an esophageal stricture that will not permit passage of the gelatin capsule or are unable to swallow the capsule.
- Vulnerable populations, such as those with diminished mental acuity, will be excluded.
- Patients with known Lidocaine/Acetylcysteine allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cytosponge/ brushing
Subjects with eosinophilic esophagitis undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease will be asked to swallow the cytosponge two hours prior to endoscopy.
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An ingestible gelatin capsule containing a compressed mesh attached to a string.
The capsule is swallowed and once in the stomach, the gelatin dissolves and a spherical mesh of 3 cm diameter is released.
The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Specificity of the Cytosponge
Time Frame: Baseline
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Percent specificity of Cytosponge ability to detect Eosinophilic Esophagitis when compared to upper endoscopy and biopsies/swab testing.
Cytology specimens will be reviewed by one pathologist who will read them blindly without knowledge of the results of the biopsy specimens.
To calculate specificity: 100% the number of true negatives divided by the sum of the number of true negatives plus the number of false positives.
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Baseline
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Percent Sensitivity of the Cytosponge
Time Frame: Baseline
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Percent sensitivity of Cytosponge ability to detect Eosinophilic Esophagitis when compared to upper endoscopy and biopsies/swab testing.
Cytology specimens will be reviewed by one pathologist who will read them blindly without knowledge of the results of the biopsy specimens.
To calculate sensitivity: 100% the number of true positives divided by the sum of the number of true positives plus the number of false negatives
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Katzka 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. Erratum In: Am J Gastroenterol. 2017 Dec 19;:
- Katzka DA, Geno DM, Ravi A, Smyrk TC, Lao-Sirieix P, Miremadi A, Debiram I, O'Donovan M, Kita H, Kephart GM, Kryzer LA, Camilleri M, Alexander JA, Fitzgerald RC. Accuracy, safety, and tolerability of tissue collection by Cytosponge vs endoscopy for evaluation of eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2015 Jan;13(1):77-83.e2. doi: 10.1016/j.cgh.2014.06.026. Epub 2014 Jul 3. Erratum In: Clin Gastroenterol Hepatol. 2015 Aug;13(8):1552. Miramedi, Ahmed [corrected to Miremadi, Ahmed].
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
June 7, 2016
Study Completion (Actual)
June 7, 2016
Study Registration Dates
First Submitted
April 23, 2012
First Submitted That Met QC Criteria
April 24, 2012
First Posted (Estimate)
April 25, 2012
Study Record Updates
Last Update Posted (Actual)
June 13, 2022
Last Update Submitted That Met QC Criteria
June 10, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-006429
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eosinophilic Esophagitis
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Children's Hospital Medical Center, CincinnatiNational Institute of Allergy and Infectious Diseases (NIAID); National Institute... and other collaboratorsCompletedEosinophilic Esophagitis (EoE) | Eosinophilic Gastrointestinal Disorders (EGIDs)United States
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Federico II UniversityRecruitingEsophagitis, EosinophilicItaly
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Ann & Robert H Lurie Children's Hospital of ChicagoRecruitingEosinophilic Gastroenteritis | Eosinophilic Esophagitis | Eosinophilic Colitis | Eosinophilic Gastrointestinal DiseaseUnited States
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Children's Hospital of PhiladelphiaRecruitingEosinophilic Esophagitis (EoE)United States
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Medical University of GrazRecruiting
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AQILION ABCompletedEosinophilic Esophagitis (EoE)United Kingdom
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Regeneron PharmaceuticalsSanofiActive, not recruitingEosinophilic Esophagitis (EoE)United States, Canada
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ShireTakeda Development Center Americas, Inc.TerminatedEosinophilic Esophagitis (EoE)United States
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ShireCompletedEosinophilic Esophagitis (EoE)United States
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ShireCompleted
Clinical Trials on Cytosponge
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University of North Carolina, Chapel HillMayo Clinic; University of Cambridge; CURED FoundationTerminatedEosinophilic Esophagitis | EoEUnited States
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Changhai HospitalThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical... and other collaboratorsEnrolling by invitationEsophageal Squamous Cell CarcinomaChina
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Columbia UniversitySuspendedBarrett Esophagus | Esophageal AdenocarcinomaUnited States
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University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National... and other collaboratorsCompletedBarrett's EsophagusUnited States
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University of OxfordCambridge University Hospitals NHS Foundation Trust; Centre for Statistics... and other collaboratorsCompletedOesophageal CancerUnited Kingdom
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International Agency for Research on CancerUniversity of Cambridge; Kilimanjaro Clinical Research InstituteCompleted
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University of North Carolina, Chapel HillAmerican Gastroenterological AssociationCompletedGERD | Barrett EsophagusUnited States
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The Hospital for Sick ChildrenRecruitingEosinophilic EsophagitisCanada
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Medtronic - MITGCompleted