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Monitoring Brain Tumor Surgery with the HIVEN® Device

This study is testing a new medical device called HIVEN® during brain tumor surgery. The device helps surgeons find tumor tissue by detecting a special glow (fluorescence) from a drug called 5-ALA (Gleolan) in the surgical suction. This glow helps surgeons see tumor cells that might otherwise be missed, which could lead to more complete tumor removal. The study aims to see if the HIVEN® device can effectively detect this fluorescence and if it is safe compared to current methods. You might be able to join if you are an adult (18-99 years old) having surgery for a suspected grade 3 or 4 glioma with 5-ALA, or for another primary or secondary brain tumor without 5-ALA. The study plans to enroll 8 participants.

Study design
This interventional study aims to enroll 8 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures performance and safety during the surgical procedure itself, through video recordings and user questionnaires.

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NCT07111182

Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery

Recruiting
NAAges 18–99InterventionalDevice feasibility
University of Illinois at Chicago
~8 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:HIVEN Medical Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstrate the increased detection of fluorescence during surgery (performance)
Measured over During procedure video recording
+1 more outcome measured

Conditions

Brain Neoplasms

Explore related trials

Brain NeoplasmGlioma

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Fady T Charbel, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Fady T Charbel, MD
[email protected]
312-996-4842
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient admitted to neurosurgery department for surgical resection of a suspected grade 3 or 4 glioma with 5-ALA (cases)
Patient admitted to neurosurgery department for surgical resection of a primary of secondary brain tumor with no 5-ALA (controls)
Patients aged 18 years old or older (all patients)
Informed consent obtained (all patients)

Exclusion

Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled.
The participants are not randomized. Randomization is not conducted as the number of eligible patients is limited, subjecting to a long recruitment period that reciprocally increases the bias from uncontrollable (evolving) surgical techniques and adjunct treatments.
The patients are screened and informed of the study before the surgical operation and enrolled after verification of eligibility and written informed consent has been received.

What this trial measures

  • Demonstrate the increased detection of fluorescence during surgery (performance)During procedure video recording

    Fluorescence detection rate during surgery measured per seconds of video (performance)

  • Assess the safety and benefit-risk profile versus a legally marketed alternative therapy i.e. visual fluorescence guidance (safety)During procedure user's questionnaires

    Benefit-risk profile based on user's systematic questionnaires indicates non-inferiority to visual fluorescence guidance (safety)