NCT05247749

CONVIVO System to Discriminate Healthy Tissues vs Tumor Tissues During Brain Tumor Resection

Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal Tissues From Abnormal Tissues During Brain Tumor Resection

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to do a direct comparison of the CONVIVO system (camera imaging device) with our normal Stanford pathology process. CONVIVO system is being tested to see if the device creates the images very quickly by touching a special camera to the surgical wound.

Detailed description

Primary Objective: The primary objective of this study is to determine the feasibility of using the CONVIVO imaging system to identify tumor type. Secondary Objective: The secondary objectives are to determine the average time needed for tissue visualization with the CONVIVO system as compared to standard cryosectioning, and to describe the ability of the CONVIVO imaging -To describe the ability of the CONVIVO imaging system to generate readable images.

Conditions

• Brain Tumor

Interventions

Type	Name	Description
DEVICE	CONVIVO Confocal Endomicroscopy System	Confocal Laser Endomicroscopy (CEM) system intended for viewing intra-operative blood flow in the cerebral vascular area. Manufacturer - Zeiss

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2022-02-21
• Last updated: 2022-02-21

Regulatory

• FDA-regulated device study