A Prospective, Multicenter, Assessor-Blinded Clinical Performance Study to Evaluate the Clinical Efficacy of the cCeLL-Ex vivo for Intraoperative Diagnosis in Brain Tumors

A prospective, multi-centered, assessor-blinded clinical performance study to evaluate the sensitivity and specificity of the proposed cell/tissue histopathology image processor cCeLL – Ex vivo (Confocal Fluorescence Endomicroscopy) for intraoperative diagnosis in brain tumors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008869

Enrollment

504

Registered

2023-10-13

Start date

2022-10-17

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Although this trial uses a single-group design, it effectively compares two approaches within the same specimens: the “cCeLL – Ex vivo T” confocal laser fluorescence microscope (test

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Tissue obtained from adults (male or female) 19 years of age or older. 2)Tissue obtained from patients suspected of having a brain tumor who are scheduled for neurosurgery and for whom tumor resection is deemed feasible. 3)Tissue obtained from patients who fully understand the contents of the informed consent document and voluntarily sign it.

Exclusion criteria

Exclusion criteria: 1) Tissue obtained from an emergency patient for whom informed consent could not be obtained prior to surgery. 2) Tissue in which hemorrhage occurred. 3) Biopsy tissue that is too small to be imaged at the specified size. 4) Unsuitable images (poor-quality imaging): (i) Poor-quality cCeLL – Ex vivo T images (ii) cCeLL – Ex vivo T images of the central tumor region that are deemed clinically invalid 5) Cases in which the principal investigator or study personnel judge participation to be ethically or clinically inappropriate, or likely to affect the results of this clinical performance study. 6) Cases involving multiple surgeries performed on the same site.

Design outcomes

Primary

Measure	Time frame
Non-inferiority of diagnostic accuracy using the cCeLL – Ex vivo confocal fluorescence microscope compared to frozen section (reference standard = permanent section pathology)	—

Secondary

Measure	Time frame
Evaluate non-inferiority of cCeLL – Ex vivo sensitivity/specificity versus frozen section;Inter-Reader Concordance for cCeLL – Ex vivo;Tumor Type Classification Accuracy;Number of Images Required and Diagnostic Time;Rate of Non-diagnostic Specimens	—

Countries

Korea, Republic of

Contacts

Public ContactYoon-Seok Jang

Korea University Anam Hospital

yoonseok93@naver.com+82-2-1577-0083

Outcome results