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Clinical Trial Summary

The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the tumor.


Clinical Trial Description

The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the bladder tumor. The recordings and overall results will be compared to standard histo/cytopathological examination of urological tissue to achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and diagnostic information established by Raman. The MIB RAMAN SYSTEM in combination with a Raman probe will be used in the operating theatre at Herlev/Copenhagen hospital urology department, where the rigid resectoscopes will be used while the trial participant is under general anesthesia. Each measurement takes about 1-5 seconds and the whole procedure with the fiber optic probes is expected to prolong the operation with 10-15 minutes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05124106
Study type Interventional
Source University Hospital Bispebjerg and Frederiksberg
Contact Gregers G Hermann, DM Sc
Phone +45 38686801
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date November 8, 2021
Completion date April 1, 2022