Cytosponge Protocol IRB 11-006429

Eosinophilic Esophagitis Clinical Trial

Official title:

Cytosponge Protocol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01585103
• Other study ID #: 11-006429
• Status: Terminated
• Phase: N/A
• Start date: December 2012
• Est. completion date: June 7, 2016

Study information

• Verified date: June 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: June 7, 2016
• Est. primary completion date: June 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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 The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	University of Cambridge

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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	Baseline

External Links

•   Mayo Clinic Clinical Trials