Status:
UNKNOWN
Allograft Adipose Injectable for Vocal Fold Paralysis
Lead Sponsor:
University of Southern California
Conditions:
Vocal Fold Palsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Renuva is allograft adipose matrix commonly used as a filler in cosmetic procedures. The investigators are studying this material as an injectable in the vocal fold to treat glottic insufficiency. C...
Detailed Description
Background/Significance: Vocal cord injection augmentation is commonly used to treat glottal insufficiency. Various materials are used for injection augmentation including autologous fat, hyaluronic ...
Eligibility Criteria
Inclusion
- • Age ≥ 18 years old
- 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 lidocaine or amide-based anesthetics
- Pregnancy
- Active infection or inflammation in the larynx (presence of acute laryngeal infection caused by bacteria/virus or fungus)
- 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 :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04700566
Start Date
May 16 2022
End Date
July 1 2025
Last Update
February 6 2023
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90033