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Filler
Silk Protein Microparticle-based Filler for Injection Augmentation
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
- Voice Disorder
- 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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,812 Total Patients Enrolled
Sofregen Medical, Inc.Industry Sponsor
8 Previous Clinical Trials
351 Total Patients Enrolled