Your session is about to expire
← Back to Search
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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreTrial 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
919 Previous Clinical Trials
1,611,430 Total Patients Enrolled
Sofregen Medical, Inc.Industry Sponsor
8 Previous Clinical Trials
351 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger