CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Silk Microparticle Filler Injectionprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03790956
NCT03790956N/ACompleted
CompareCT.gov

Safety and Efficacy of a Silk Protein Microparticle-based Filler for Injection Augmentation in Treating Unilateral Vocal Fold Paralysis

University of Southern California·interventional·Posted Jan 2, 2019·Updated May 10, 2023

In Brief

A clinical study evaluating Silk Microparticle Filler Injection for Vocal Cord Paralysis Unilateral and 2 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVocal Cord Paralysis Unilateral, Dysphonia, Dysphagia, Oropharyngeal
CountriesUnited States
CollaboratorsSofregen Medical, Inc.

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 2, 2019
Enrollment StartJul 1, 2020
Primary CompletionMar 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.5 years ago

Interventions

Silk Microparticle Filler Injectionprocedure

A silk protein microparticle-based filler will be injected deep to the thyroarytenoid muscle of the paralyzed vocal fold to augment/medialize its position.