Cytosponge Protocol IRB 11-006429
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| ClinicalTrials.gov Identifier: NCT01585103 |
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Recruitment Status :
Terminated
(Device was recalled by company)
First Posted : April 25, 2012
Results First Posted : May 18, 2022
Last Update Posted : June 13, 2022
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Sponsor:
Mayo Clinic
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Eosinophilic Esophagitis | Device: Cytosponge | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 86 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Cytosponge Protocol |
| Study Start Date : | December 2012 |
| Actual Primary Completion Date : | June 7, 2016 |
| Actual Study Completion Date : | June 7, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Eosinophilic Esophagitis
| Arm | Intervention/treatment |
|---|---|
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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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Device: Cytosponge
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 The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected. |
Primary Outcome Measures :
- Percent Specificity of the Cytosponge [ Time Frame: Baseline ]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.
- Percent Sensitivity of the Cytosponge [ Time Frame: Baseline ]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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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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): NCT01585103
Locations
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
University of Cambridge
Investigators
| Principal Investigator: | Jeffrey Alexander, MD | Mayo Clinic |
Study Documents (Full-Text)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeffrey A Alexander, Prinicipal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01585103 |
| Other Study ID Numbers: |
11-006429 |
| First Posted: | April 25, 2012 Key Record Dates |
| Results First Posted: | May 18, 2022 |
| Last Update Posted: | June 13, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
Additional relevant MeSH terms:
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Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |