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Cytosponge Protocol IRB 11-006429

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ClinicalTrials.gov Identifier: NCT01585103
Recruitment Status : Recruiting
First Posted : April 25, 2012
Last Update Posted : April 14, 2020
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

Study Description
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Brief Summary:
Whether the cytosponge will be a useful non-invasive tool in evaluating patients with eosinophilic esophagitis?

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Device: Cytosponge - Brushing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cytosponge Protocol
Study Start Date : December 2012
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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  • The back of the throat is then sprayed with 1% lidocaine and the expanded mesh withdrawn by pulling on the string with the patient's head in an extended position.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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585103


Contacts
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Contact: Crystal J Lavey, CCRP 507-538-1361 lavey.crystal@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Crystal J Lavey, CCRP    507-538-1361    lavey.crystal@mayo.edu   
Principal Investigator: David Katzka, M.D.         
Sponsors and Collaborators
Mayo Clinic
University of Cambridge
Investigators
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Principal Investigator: David Katzka, MD Mayo Clinic
More Information
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Additional Information:

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

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Responsible Party: David A. Katzka, Prinicipal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01585103    
Other Study ID Numbers: 11-006429
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
 Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases