Status:
COMPLETED
Silk Protein Microparticle-based Filler for Injection Augmentation
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Sofregen Medical, Inc.
Conditions:
Vocal Cord Paralysis Unilateral
Dysphonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will investigate the safety and efficacy of a silk protein microparticle-based filler for vocal fold injection augmentation to treat dysphonia/dysphagia secondary to vocal fold paralysis. P...
Detailed Description
Vocal fold paralysis is a clinical condition that arises commonly as a complication of surgery, endotracheal intubation, malignancy, or idiopathic etiologies. It often results in glottal insufficiency...
Eligibility Criteria
Inclusion
- Unilateral vocal fold immobility with glottal insufficiency present for at least 2 weeks from onset
- Willingness to partake in study and follow-up as documented by signed informed consent
Exclusion
- History of allergy/hypersensitivity to silk or silk containing products
- History of allergy/hypersensitivity to hyaluronic acid (HA) or HA containing products
- History of allergy/hypersensitivity to lidocaine or amide-based anesthetics
- History of an autoimmune condition
- Significant immunocompromised state (i.e. immunosuppression s/p transplantation)
- Pregnancy
- Active infection or inflammation in the larynx
- Comorbid known laryngeal conditions including but not limited to vocal fold scar, vocal tremor, laryngeal dystonia, etc. that would warrant other interventions for optimal treatment
- History of laryngeal surgery
- Life expectancy of less than 6 months
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03790956
Start Date
July 1 2020
End Date
March 15 2023
Last Update
May 10 2023
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90033