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Filler

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

Study Summary

This trial will test a new protein-based filler for treating voice and swallowing problems caused by paralysis of the vocal cords. Patients will get one injection and be monitored for 12 months.

Eligible Conditions
  • Unilateral Vocal Cord Paralysis
  • Oropharyngeal Dysphagia
  • Hoarseness

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
918 Previous Clinical Trials
1,611,566 Total Patients Enrolled
Sofregen Medical, Inc.Industry Sponsor
8 Previous Clinical Trials
351 Total Patients Enrolled
~2 spots leftby Jun 2025