Cytosponge Protocol IRB 11-006429

Not Applicable

Terminated

• Conditions: Eosinophilic Esophagitis
• Interventions: Device: Cytosponge

• Registration Number: NCT01585103
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Study Start: 2012-12
• Primary Completion: 2016-06-07
• Study Completion: 2016-06-07
• Results First Submitted: 2022-04-22
• Results First Submitted QC: 2022-04-22
• Results First Posted: 2022-05-18
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytosponge/ brushing	Cytosponge	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.

Primary Outcome Measures

Name	Time	Method
Percent Specificity of the Cytosponge	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	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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States