CONVIVO Endomicroscopy

NCT06087393 | Unknown FDA Device

• 1 other identifier: 21-1289
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumor

Outcome Measures

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.

  one year

Interventions

CONVIVO DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

Related Publications (1)

• Acerbi, F., Pollo, B., De Laurentis, C., Restelli, F., Falco, J., Vetrano, I. G., ... & DiMeco, F. (2020). Ex Vivo Fluorescein-Assisted Confocal Laser Endomicroscopy (CONVIVO® System) in Patients With Glioblastoma: Results From a Prospective Study. Frontiers in Oncology, 10. Belykh, E., Miller, E. J., Patel, A. A., Yazdanabadi, M. I., Martirosyan, N. L., Yağmurlu, K., ... & Preul, M. C. (2018). Diagnostic accuracy of a confocal laser endomicroscope for in vivo differentiation between normal injured and tumor tissue during fluorescein-guided glioma resection. World neurosurgery, 115, e337-e348

  BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Betsy Moclair

CONTACT

5162537753; bmoclair@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is single cohort and plans to enroll a total of 30 patients.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 17, 2023
• Study Start: January 8, 2024
• Primary Completion: October 12, 2024
• Study Completion: October 12, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Locations

US (1)