Status:
COMPLETED
Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
Lead Sponsor:
University of Southern California
Conditions:
Presbylarynx
Atrophy; Larynx
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis...
Detailed Description
Vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging Americans, up to 35% of those 65 or older. Currently used treatment ...
Eligibility Criteria
Inclusion
- Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
- Patients with a pre-injection VHI-10 score of ≥ 10
- Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
- Ability to give informed consent
Exclusion
- Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
- Current smoker
- Underlying coagulopathy, thrombocytopenia, or platelet dysfunction
Key Trial Info
Start Date :
February 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03749863
Start Date
February 18 2020
End Date
September 30 2022
Last Update
May 10 2023
Active Locations (1)
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1
University of Southern California
Los Angeles, California, United States, 90033