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Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy: Discrete Pulmonary Lesions and Acute Rejection in Transplanted Lungs
Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants. The hypothesis is that bronchoscopy together with probe-based endomicroscopy (pCLE)results in improved and/or incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.
The primary aim of this study is to develop the criteria to differentiate healthy versus diseased tissue in patient with discrete lung lesions or to characterize acute lung rejection in patients with transplanted lungs. Once these criteria have been defined, the diagnostic parameters and the reproducibility of pCLE will be assessed.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
St. Joseph's Medical Center
Phoenix, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Columbus Regional Hospital
Columbus, Indiana, United States
University of Louisiana Shreveport
Shreveport, Louisiana, United States
Walter Reed Military Medical Center
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Rochester
Rochester, New York, United States
Ohio State University
Columbus, Ohio, United States
Start Date
February 1, 2013
Primary Completion Date
December 24, 2016
Completion Date
December 24, 2016
Last Updated
August 29, 2017
99
ACTUAL participants
probe based laser endomicroscopy (pCLE)
DEVICE
Lead Sponsor
Mauna Kea Technologies
NCT07143110
NCT06885697
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04577599