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Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients. This study is also being conducted to determine if use of the Orbeye equipped with these special filters improves the ability of the surgeon to remove brain tumors.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
H. Lee Moffitt Cancer and Research Institute
Tampa, Florida, United States
Start Date
August 15, 2019
Primary Completion Date
December 17, 2019
Completion Date
February 23, 2021
Last Updated
May 31, 2022
20
ACTUAL participants
Orbeye surgical videomicroscope
DEVICE
5-Aminolevulinic Acid
DRUG
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
NCT05099003
NCT06860594
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 ConditionsNCT05839379