CONVIVO Endomicroscopy
ConditionBrain Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNorthwell Health
About this trial
Visualization of the tissue microstructure during neurosurgery using a non destructive handheld imaging technology producing a real time digital image ("optical biopsy") at cellular resolution is a novel method that holds great promise for optimization and improvement of the surgical treatment of brain pathologies, brain tumors in particular. The goal of this project is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients undergoing neurosurgical resection for intrinsic presumably high grade, invasive tumors.
Patients undergoing neurosurgical resection for other brain tumors,.
All patient groups will only be comprised of elective surgical patients who have signed the informed consent prior to use
Disqualifiers
History of hypersensitivity to fluorescein
History of allergy or bronchial asthma
Renal failure - Children (patients less than 18 years of age)
Pregnant women
Trial design
Design model
Single group
Treatments tested in this trial
CONVIVO
DeviceAny clinical adverse event (AE), laboratory abnormality, or other medical condition or situation occurs such that continued participation in the study would not be in the best interest of the participant. The participant meets an exclusion criterion (either newly developed or not previously recognized) that precludes further study participation.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Investigate ease of CONVIVO.
The outcome is to investigate and assess the ease of use of the CONVIVO FDA cleared system in discriminating healthy and abnormal tissues during in vivo use on the brain during neurosurgery in 30 patients with a working diagnosis of intrinsic brain tumors.
Time frame
one yearSponsors and contacts
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Source ClinicalTrials.gov