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NCT03585075 Clinical Trial

Characterization of the Autofluorescence of Healthy and Pathological Tissues of Vocal Cords

Laryngeal Neoplasms Clinical Trial

— FLUOROCORD  

Official title:
Caractérisation de l'Autofluorescence Des Tissus Sains et Pathologiques Des Cordes Vocales

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03585075
Other study ID # P/2014/216
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2014
Est. completion date April 2016

Study information
Verified date June 2018
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this clinical trial is to provide information about autofluorescence of pathological versus healthy vocal folds tissues.

Experimentations are performed on vocal folds biopsies obtained from patients, surgered at ENT department, university hospital of Besançon. After being extracted, samples of vocal folds are submitted to excitations at 365 nm, 405 nm and 450 nm; light spectral absorptions are measured, and results are compared to reference anatomopathology.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 2016
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient view in ENT department, presenting vocal fold lesion that necessitate biopsy

- patient informed and with non opposition

Exclusion Criteria:

- small (<1mm) and/or brittle sample

- Patients in emergency situations, pregnant or nursing mothers, persons deprived of their liberty, minors or protected adults.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Besancon Besancon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary hyperspectral fluorescence of vocal folds 30 minutes after biopsy
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