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Cytosponge Protocol IRB 11-006429

Primary Purpose

Eosinophilic Esophagitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytosponge
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Eosinophilic Esophagitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cytosponge/ brushing

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent Specificity of the Cytosponge
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
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

Secondary Outcome Measures

Full Information

First Posted
April 23, 2012
Last Updated
June 10, 2022
Sponsor
Mayo Clinic
Collaborators
University of Cambridge
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1. Study Identification

Unique Protocol Identification Number
NCT01585103
Brief Title
Cytosponge Protocol IRB 11-006429
Official Title
Cytosponge Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Device was recalled by company
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 7, 2016 (Actual)
Study Completion Date
June 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of Cambridge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cytosponge/ brushing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cytosponge
Intervention Description
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 Measure Information:
Title
Percent Specificity of the Cytosponge
Description
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.
Time Frame
Baseline
Title
Percent Sensitivity of the Cytosponge
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Alexander, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28809387
Citation
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;:
Results Reference
derived
PubMed Identifier
24997328
Citation
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].
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Cytosponge Protocol IRB 11-006429

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