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NCT06227585 · ClinicalTrials.gov registry record · Phase 2

Feasibility and Efficacy Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery

A Phase 2 study, sponsored by Alume Biosciences.

Completed
Registry status
Phase 2
Development phase
155
Enrollment target

NCT06227585: Completed Phase 2 study, sponsored by Alume Biosciences.

NCT06227585 is a Phase 2 study that has completed, run by Alume Biosciences. The registered enrollment target is 155 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06227585, a Phase 2 study, has completed, sponsored by Alume Biosciences.

COMPLETED
Registry status
Phase 2
Development phase
155 participants
Enrollment target

Study Summary

A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on illumination and ease of use. A Part 2 Phase 3 safety and efficacy study to evaluate conspicuity of the identified nerve due to bevonescein through the use of the Visualization Scoring System (VSS).

Primary Outcome

Surgeon assessment to questions

Interventions

  • DRUG Bevonescein
  • DEVICE REVEAL 475 System

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2023-11-29
Est. Completion 2025-11-24
Phase Phase 2
Alume Biosciences

4 total trials

What the finished NCT06227585 record still lists

NCT06227585 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).

The record links to 0 conditions, and to 2 interventions - of which Bevonescein is the first listed.

NCT06227585 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06227585 about?

NCT06227585 is a clinical study titled "Feasibility and Efficacy Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery". A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on illumination and ease of use. A Part 2 Phase 3 safety and efficacy study to evaluate conspicuity of the identified nerve due to bevonescein through the use of the Vi...

What is the current status of trial NCT06227585?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2023-11-29. Estimated completion is 2025-11-24.

What interventions are being tested in trial NCT06227585?

The interventions under investigation include: Bevonescein (DRUG), REVEAL 475 System (DEVICE).

Who is sponsoring clinical trial NCT06227585?

This trial is sponsored by Alume Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06227585's enrollment target sits among peer trials

155 448th of 2000 higher than 1,553 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06227585, the US trial registry maintained by the National Library of Medicine. NCT06227585 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.