19 and older, any sex, with Benign Brain Tumor or Malignant Brain Tumor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Sensitivity for Tumor Detection (Specimen-level)Primary· From neurosurgical resection to permanent pathology (≈ 4 weeks)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 283 tumor specimens are presented below.
cCeLL - Ex vivo
Group
Value
95% CI
cCeLL - Ex vivo and Frozen Section
96.05
92.80 – 98.30
Frozen section
Group
Value
95% CI
cCeLL - Ex vivo and Frozen Section
94.81
92.18 – 96.76
Clinical Specificity for Tumor Detection (Specimen-level)Primary· From neurosurgical resection to permanent pathology (≈ 4 weeks)
The diagnostic results of cCeLL - Ex vivo imaging interpretation by experts and frozen section examination for 39 normal specimens are as follows
Frozen Section
Group
Value
95% CI
cCeLL - Ex vivo and Frozen Section
67.86
54.2 – 79.1
cCeLL - Ex vivo
Group
Value
95% CI
cCeLL - Ex vivo and Frozen Section
78.57
65 – 89.9
Sponsor's own description
Intra-operative evaluation of residual brain tumor currently relies on frozen-section histopathology, which typically requires 20-30 minutes for tissue processing and interpretation, prolonging operative time and increasing staffing demands. Confocal Laser Fluorescence Microscopy (cCeLL - Ex vivo) acquires real-time, high-resolution fluorescence images of resected tissue and therefore may serve as a rapid alternative or adjunct to frozen sections. This prospective, multi-center study was designed to systematically assess the clinical performance of cCeLL - Ex vivo during brain-tumor surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT07254845 — A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HIS
· Phase 1
· not yet recruiting
NCT06867978 — Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.
· Phase 1
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VPIX Medical
Last refreshed: 15 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06098248.