RecruitingNot ApplicableNCT06087393

CONVIVO Endomicroscopy

A Feasibility Analysis of an in Vivo CONVIVO Endomicroscopy During Brain Surgery.


Sponsor

Northwell Health

Enrollment

30 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Inclusion Criteria4

  • The patient is suffering from an intracranial lesion requiring surgery:
  • 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

Exclusion Criteria6

  • History of hypersensitivity to fluorescein
  • History of allergy or bronchial asthma
  • Renal failure - Children (patients less than 18 years of age)
  • Pregnant women
  • Breast feeding women
  • Patients with inability to give informed consent

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Interventions

DEVICECONVIVO

Any 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.


Locations(1)

Northwell Health

Manhasset, New York, United States

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NCT06087393


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