Cytosponge Protocol IRB 11-006429

This study is currently recruiting participants.

See

Contacts and Locations

Verified July 2016 by David A. Katzka, Mayo Clinic

Sponsor:

Collaborator:

University of Cambridge

Information provided by (Responsible Party):

David A. Katzka, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01585103

First received: April 23, 2012

Last updated: July 19, 2016

Last verified: July 2016

History of Changes

Purpose

Whether the cytosponge will be a useful non-invasive tool in evaluating patients with eosinophilic esophagitis?

Condition	Intervention
Eosinophilic Esophagitis	Device: Cytosponge - Brushing


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic
Official Title:	Cytosponge Protocol

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Eosinophilic Enteropathy

U.S. FDA Resources

Further study details as provided by David A. Katzka, Mayo Clinic:

Primary Outcome Measures:

Evaluate sensitivity and specificity of the Cytosponge in patient's with Eosinophilic Esophagitis [ Time Frame: Six months ]
To evaluate the sensitivity and specificity of Cytosponge when compared to upper endoscopy and biopsies/brushing in patients undergoing clinically indicated endoscopy for evaluation of Eosinophilic Esophagitis.


Estimated Enrollment:	120
Study Start Date:	December 2012
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	May 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cytosponge/ brushing	Device: Cytosponge - Brushing Patients with eosinophilic esophagitis will be enrolled. Undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease. Two hours prior to endoscopy in the patients will be asked to swallow the Cytosponge. Briefly, the capsule and bunched up string are swallowed with water. The string is held without any tension to allow the capsule to move into the stomach. The patient holds onto the string for five minutes after ingestion to allow the capsule to dissolve in the proximal stomach, where a spherical mesh of 3 cm diameter is released. The back of the throat is then sprayed with 1% lidocaine and the expanded mesh withdrawn by pulling on the string with the patient's head in an extended position. Following this, the clinically indicated endoscopy will be performed. Prior to biopsies we will do a brushing of the esophagus. Other Names: New diagnostic tools for Barrett's and Eosinophilic Esophagitis

Arms

Assigned Interventions

Experimental: Cytosponge/ brushing

Device: Cytosponge - Brushing

Patients with eosinophilic esophagitis will be enrolled. Undergoing clinically indicated endoscopy and biopsy either for initial diagnosis or for monitoring the activity of their disease.
Two hours prior to endoscopy in the patients will be asked to swallow the Cytosponge. Briefly, the capsule and bunched up string are swallowed with water.
The string is held without any tension to allow the capsule to move into the stomach. The patient holds onto the string for five minutes after ingestion to allow the capsule to dissolve in the proximal stomach, where a spherical mesh of 3 cm diameter is released.
The back of the throat is then sprayed with 1% lidocaine and the expanded mesh withdrawn by pulling on the string with the patient's head in an extended position.
Following this, the clinically indicated endoscopy will be performed. Prior to biopsies we will do a brushing of the esophagus.

Other Names:

New diagnostic tools
for Barrett's and
Eosinophilic Esophagitis

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585103

Contacts


Contact: Debra M. Geno, CCRP	507-538-0367	geno.debra@mayo.edu
Contact: Katrina J Pierce	507-538-1361	pierce.katrina@mayo.edu

Locations


United States, Minnesota
Mayo Clinic in Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M Geno, CCRP 507-538-0367 geno.debra@mayo.edu
Contact: Katrina J Pierce 507-538-1361 pierce.katrina@mayo.edu
Principal Investigator: David Katzka, M.D.

Sponsors and Collaborators

Mayo Clinic

University of Cambridge

Investigators


Principal Investigator:	David Katzka, MD	Mayo Clinic

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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].


Responsible Party:	David A. Katzka, Prinicipal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01585103 History of Changes
Other Study ID Numbers:	11-006429
Study First Received:	April 23, 2012
Last Updated:	July 19, 2016

Additional relevant MeSH terms:


Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis	Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017

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