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Cytosponge Protocol IRB 11-006429

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01585103
Recruitment Status : Terminated (Device was recalled by company)
First Posted : April 25, 2012
Results First Posted : May 18, 2022
Last Update Posted : June 13, 2022
Sponsor:
Collaborator:
University of Cambridge
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 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
Actual Primary Completion Date : June 7, 2016
Actual Study Completion Date : June 7, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cytosponge/ brushing
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.
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 The mesh is withdrawn through the mouth by the attached string and a cytologic specimen is collected.




Primary Outcome Measures :
  1. Percent Specificity of the Cytosponge [ Time Frame: Baseline ]
    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.

  2. Percent Sensitivity of the Cytosponge [ Time Frame: Baseline ]
    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



Information from the National Library of Medicine

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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

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


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Cambridge
Investigators
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Principal Investigator: Jeffrey Alexander, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Jeffrey A Alexander, Mayo Clinic:
Study Protocol  [PDF] November 24, 2021

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeffrey A Alexander, Prinicipal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01585103    
Other Study ID Numbers: 11-006429
First Posted: April 25, 2012    Key Record Dates
Results First Posted: May 18, 2022
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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