← Back to Search

Filler

Silk Microparticle Filler Injection for Unilateral Vocal Cord Paralysis

N/A

Waitlist Available

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test a new protein-based filler for treating voice and swallowing problems caused by paralysis of the vocal cords. Patients will get one injection and be monitored for 12 months.

Eligible Conditions

Unilateral Vocal Cord Paralysis
Oropharyngeal Dysphagia
Hoarseness

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale

Secondary outcome measures

Objective Acoustic Testing as assessed by Cepstral Peak Prominence (CPP)

Objective Acoustic Testing as assessed by Sound Pressure Level (SPL)

Objective Acoustic Testing as assessed by fundamental frequency

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Silk Microparticle Filler InjectionExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Silk Microparticle Filler Injection

2020

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,307 Total Patients Enrolled

Sofregen Medical, Inc.Industry Sponsor

8 Previous Clinical Trials

351 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants in this experiment?

"Affirmative. The clinical trial database hosted on clinicialtrials.gov states that this investigation, which was first revealed to the public on July 1st 2020, is presently enrolling patients. A total of 100 volunteers are needed from a single medical centre for inclusion in this study."

Answered by AI

Are they presently recruiting patients for this clinical trial?

"Affirmative. The records on clinicaltrials.gov verify that this research is presently recruiting subjects; the trial was first posted on July 1st 2020 and its details were updated most recently in December 2021. Currently, 100 individuals are being admitted at one site for testing purposes."

Answered by AI

Recent research and studies

Journal of PeriodontologyJournal

Soft Tissue Augmentation Using Silk Gels: An in Vitro and in Vivo Study

Etienne, Olivier, Aurore Schneider, Jonathan A. Kluge, Claire Bellemin‐Laponnaz, Camille Polidori, Gary G. Leisk, David L. Kaplan, Jonathan A. Garlick, and Christophe Egles. 2009. “Soft Tissue Augmentation Using Silk Gels: An in Vitro and in Vivo Study”. Journal of Periodontology. Wiley. doi:10.1902/jop.2009.090231.

Journal of Plastic, Reconstructive & Aesthetic SurgeryJournal

In Vivo Characterization of the Integration and Vascularization of a Silk-derived Surgical Scaffold

Kijanska, Monika, Anastasios Marmaras, Alicia Hegglin, Vartan Kurtcuoglu, Pietro Giovanoli, and Nicole Lindenblatt. 2016. “In Vivo Characterization of the Integration and Vascularization of a Silk-derived Surgical Scaffold”. Journal of Plastic, Reconstructive & Aesthetic Surgery. Elsevier BV. doi:10.1016/j.bjps.2016.01.017.

Otolaryngology–Head and Neck SurgeryJournal

Quality-of-life Assessment in Patients with Unilateral Vocal Cord Paralysis

Spector, Brian C., James L. Netterville, Cheryl Billante, Janye Clary, Lou Reinisch, and Timothy L. Smith. 2001. “Quality-of-life Assessment in Patients with Unilateral Vocal Cord Paralysis”. Otolaryngology–head and Neck Surgery. SAGE Publications. doi:10.1067/mhn.2001.117714.

Journal of VoiceJournal