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Procedure

Single Arm (Bevonescein) for Head and Neck Surgery

Phase 2

Recruiting

Research Sponsored by Alume Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum of 16 years of age

Planning to undergo surgery in the Head and Neck

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after surgery

Awards & highlights

Study Summary

This trial is testing the REVEAL 475 system to see how well it can be used during surgery to help doctors see nerves.

Who is the study for?

This trial is for patients undergoing head and neck surgery who may benefit from enhanced nerve visualization. Specific eligibility criteria are not provided, but typically participants would need to be suitable candidates for the surgical procedure and the investigational imaging system.Check my eligibility

What is being tested?

The study is testing the REVEAL 475 system used with bevonescein, a dye that helps surgeons see nerves more clearly during operations. The goal is to assess how well this technology works in making surgeries safer by improving nerve visibility.See study design

What are the potential side effects?

Potential side effects are not detailed here, but they might include reactions to bevonescein or issues related to the imaging system's use. Generally, risks could involve allergic responses or complications affecting surgical outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 16 years old.

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I am scheduled for surgery in my head or neck area.

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My main surgery was on my salivary gland, thyroid, or neck.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgeon perspective on REVEAL 475 system blue light illumination

Surgeon perspective on REVEAL 475 system ease of use

Secondary outcome measures

Plasma concentration of bevonescein

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Arm (Bevonescein)Experimental Treatment2 Interventions

All patients will receive a single administration of bevonescein 500mg via IV infusion and the REVEAL 475 system will be used on all patients.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alume Biosciences, Inc.Lead Sponsor

2 Previous Clinical Trials

241 Total Patients Enrolled

ErgomedIndustry Sponsor

10 Previous Clinical Trials

3,151 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Single Arm (Bevonescein) treatment received official approval from the FDA?

"The safety of Single Arm (Bevonescein) in this Phase 2 trial is estimated to be at a level 2. While there are some supporting safety data, no efficacy data has been established yet."

Answered by AI

Are there any ongoing efforts to enroll patients in this current medical study?

"Indeed, clinicaltrials.gov indicates that this study is currently in the process of recruiting patients. The initial posting date for this trial was November 29th, 2023, and it underwent its most recent update on January 18th, 2024."

Answered by AI

At how many distinct sites can this study be accessed?

"This study is currently being conducted at 7 active sites, including renowned institutions such as Jacobs Medical Center at UC San Diego Health in San Diego, Harvard-Mass Eye & Ear in Boston, and University of New mexico in Albuquerque. Additionally, there are 7 other locations where the trial is taking place."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"A total of 80 eligible candidates who meet the specified inclusion criteria are required to participate in this clinical trial. Patients have the opportunity to enroll from multiple locations, including Jacobs Medical Center at UC San Diego Health in San Diego, California and Harvard-Mass Eye & Ear in Boston, Massachusetts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility Study- REVEAL 475 for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery

2023. "Feasibility Study- REVEAL 475 for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227585.

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