Recruiting

CONVIVO

Sponsor:

Northwell Health

Code:

NCT06087393

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

CONVIVO

Study Details

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

Study ID

NCT06087393

Start date

Jan 8, 2024

Status verified date

Jun, 2026

Completion date

Oct 12, 2026

Anticipated

Primary completion date

Oct 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • . 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 Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Interventions

CONVIVO

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.

Primary outcome measure

  • Investigate ease of CONVIVO. [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Betsy Moclair

5162537753bmoclair@northwell.edu

Locations

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Betsy Moclair

516-253-7753bmoclair@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-04.