Silk Microparticle Filler Injection for Unilateral Vocal Cord Paralysis

N/A

Waitlist Available

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new silk protein filler injected into the vocal folds to help people with vocal fold paralysis. The goal is to improve their ability to speak and swallow by making the vocal folds close better. The study will check if this treatment is safe and effective over time.

Eligible Conditions

Unilateral Vocal Cord Paralysis
Abductor Dysphonia
Oropharyngeal Dysphagia
Hoarseness

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale

Secondary study objectives

Objective Acoustic Testing as assessed by Cepstral Peak Prominence (CPP)

Objective Acoustic Testing as assessed by Sound Pressure Level (SPL)

Objective Acoustic Testing as assessed by fundamental frequency

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Silk Microparticle Filler InjectionExperimental Treatment1 Intervention

A silk protein microparticle-based filler will be injected deep to the thyroarytenoid muscle of the paralyzed vocal fold to augment/medialize its position.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Silk Microparticle Filler Injection

2020

N/A

~20

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