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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: Open Label
Primary Purpose: Diagnostic
Official Title: Cytosponge Protocol

Resource links provided by NLM:

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  • The back of the throat is then sprayed with 1% lidocaine and the expanded mesh withdrawn by pulling on the string with the patient's head in an extended position.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

  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):

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 May 25, 2017