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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 is a Phase 2 study that has completed, run by Alume Biosciences. The registered enrollment target is 155 participants.
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).
Interventions
- DRUG Bevonescein
- DEVICE REVEAL 475 System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2025-11-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06227585
The ClinicalTrials.gov registry entry for NCT06227585 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alume Biosciences, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bevonescein is the first listed.
NCT06227585 reports 0 study locations.
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.
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