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Silk Protein Microparticle-based Filler for Injection Augmentation

NCT03790956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-05-10

No results posted yet for this 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.

Conditions

  • Vocal Cord Paralysis Unilateral
  • Dysphonia
  • Dysphagia, Oropharyngeal

Interventions

PROCEDURE

Silk Microparticle Filler Injection

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

Sponsors & Collaborators

  • Sofregen Medical, Inc.

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-03-15
Completion
2023-03-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790956 on ClinicalTrials.gov