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NCT05377554 · ClinicalTrials.gov registry record · Phase 3

Bevonescein for Intra-Operative Nerve Visualization in Head and Neck Surgery

A Phase 3 study, sponsored by Alume Biosciences.

Completed
Registry status
Phase 3
Development phase
154
Enrollment target

NCT05377554: Completed Phase 3 study, sponsored by Alume Biosciences.

NCT05377554 is a Phase 3 study that has completed, run by Alume Biosciences. The registered enrollment target is 154 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05377554, a Phase 3 study, has completed, sponsored by Alume Biosciences.

COMPLETED
Registry status
Phase 3
Development phase
154 participants
Enrollment target

Study Summary

This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.

Primary Outcome

Nerve Conspicuity will be compared between WLR and WLR with FL Overlay Using the Visualization Scoring System.

Interventions

  • DRUG Bevonescein
  • OTHER Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay
  • OTHER Intra-operative Visualization using White Light Reflectance (WLR)

Trial Details

FieldValue
Enrollment Target 154 participants
Start Date 2022-04-29
Est. Completion 2025-11-24
Phase Phase 3
Alume Biosciences

4 total trials

What the finished NCT05377554 record still lists

NCT05377554 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 3 interventions - of which Bevonescein is the first listed.

NCT05377554 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05377554 about?

NCT05377554 is a clinical study titled "Bevonescein for Intra-Operative Nerve Visualization in Head and Neck Surgery". This protocol describes prospective, open-label, blinded, randomized controlled, multicenter pivotal studies to evaluate bevonescein.

What is the current status of trial NCT05377554?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 154 participants. The study started on 2022-04-29. Estimated completion is 2025-11-24.

What interventions are being tested in trial NCT05377554?

The interventions under investigation include: Bevonescein (DRUG), Intraoperative Visualization using White Light Reflectance (WLR) with Fluorescence (FL) Overlay (OTHER), Intra-operative Visualization using White Light Reflectance (WLR) (OTHER).

Who is sponsoring clinical trial NCT05377554?

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 NCT05377554's enrollment target sits among peer trials

154 1509th of 2000 higher than 491 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT05377554, the US trial registry maintained by the National Library of Medicine. NCT05377554 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.