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NCT03790956 · ClinicalTrials.gov registry record · NA
Silk Protein Microparticle-based Filler for Injection Augmentation
A NA study of Dysphonia and Dysphagia, Oropharyngeal, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT03790956: Completed NA study of Dysphonia and Dysphagia, Oropharyngeal, sponsored by University of Southern California.
NCT03790956 is a NA study of Dysphonia and Dysphagia, Oropharyngeal that has completed, run by University of Southern California. The registered enrollment target is 11 participants, below the 60-participant average among 7 other Dysphonia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03790956, a NA study of Dysphonia and Dysphagia, Oropharyngeal, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study 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. Participants will receive one injection and follow-up for a planned period of 12 months.
Primary Outcome
Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening.
Conditions Studied
Interventions
- PROCEDURE Silk Microparticle Filler Injection
Study Locations (1)
California
- University of Southern California - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2023-03-15 |
| Phase | NA |
What the finished NCT03790956 record still lists
NCT03790956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 7 other Dysphonia trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Dysphonia appearing as the primary indexed condition, and to 1 intervention - of which Silk Microparticle Filler Injection is the first listed.
NCT03790956 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03790956 about?
NCT03790956 is a clinical study titled "Silk Protein Microparticle-based Filler for Injection Augmentation". 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. Participants will receive one injection and follow-up for a planned period of 12 months.
What is the current status of trial NCT03790956?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2020-07-01. Estimated completion is 2023-03-15.
What conditions does trial NCT03790956 study?
This clinical trial studies the following conditions: Dysphonia, Dysphagia, Oropharyngeal, Vocal Cord Paralysis Unilateral.
What interventions are being tested in trial NCT03790956?
The interventions under investigation include: Silk Microparticle Filler Injection (PROCEDURE).
Who is sponsoring clinical trial NCT03790956?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03790956 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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