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NCT06867978: PRECISION

Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.

Not yet recruiting Phase 1 Last updated 10 March 2025
What this trial tests

Phase 1 trial testing cCeLL In vivo in Frozen Sections in 100 participants. Not yet recruiting.

Timeline
1 June 2025
Primary endpoint
30 June 2026
31 December 2026

Quick facts

Lead sponsorVPIX Medical
PhasePhase 1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment100
Start date1 June 2025
Primary completion30 June 2026
Estimated completion31 December 2026

Drugs / interventions tested

Conditions studied

Sponsor

VPIX Medical

Who can join

18 and older, any sex, with Frozen Sections or Indocyanine Green. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this study is to demonstrate the non-inferiority of cCeLL compared to frozen section analysis. The investigational device is intended for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovascular before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection, which is then read and analyzed by trained-professional for intraoperative diagnosis. The comparison will be held by the device with the conventional intraoperative histological frozen section analysis of identical brain tissue samples in the same patient. Both methods will be compared in terms of their accuracy using the standard of practice, the final pathological diagnosis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of cCeLL In vivo

Trials testing the same drug.

Other VPIX Medical trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT06867978.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing