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Rapid brain tumor detection device tested in operating room

NCT ID NCT06098248

Diagnosis Sponsor: VPIX Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new imaging device called cCeLL-Ex vivo that uses laser microscopy to quickly detect brain tumors during surgery. The goal was to see if it could diagnose tumors faster than the standard frozen section method, which takes 20-30 minutes. The study enrolled 285 patients but was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cCeLL-Ex vivo device (confocal laser fluorescence microscopy)
What this could lead to
If successful, this device could help surgeons diagnose brain tumors faster during surgery, potentially reducing operating time.
What could go wrong
The study was terminated early, so results are limited. The device is still experimental and not yet proven to replace standard methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

285 people

The number who actually took part.

Started

Jan 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Specimens and images used in this study must meet all of the following criteria: 1. Tissue obtained from male or female patients aged 19 years or older. 2. Tissue collected from patients scheduled for neurosurgical resection of a suspected brain tumor. 3. Tissue obtained from patients capable of understanding and signing the informed consent form. Exclusion Criteria Specimens and images that meet any of the following criteria will be excluded from the study: 1. Emergency cases where informed consent could not be obtained before surgery. 2. Specimens with significant hemorrhage, affecting image quality. 3. Small biopsy specimens that do not meet the required size for imaging. 4. Poor-quality images that do not meet study criteria, including: * Low-quality cCeLL - Ex vivo images. * Non-diagnostic cCeLL - Ex vivo images of the tumor core. 5. Cases deemed inappropriate for the study by the principal investigator or study staff due to ethical concerns or potential impact on study results. 6. Patients undergoing multiple surgeries at the same site.

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Conditions

The condition(s) this trial relates to.

benign neoplasm of brain brain cancer brain neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign brain tumor Malignant brain tumor

Contacts and locations

Locations

  • Korea University Anam Hospital

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

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