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
- Oropharyngeal Dysphagia
- Unilateral Vocal Cord Paralysis
- Hoarseness
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 14 Secondary · Reporting Duration: 12 months
12 months
Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale
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
Objective Aerodynamic Testing as assessed by Cough Velocity (CV)
Objective Aerodynamic Testing as assessed by Maximum Phonation Time (MPT)
Objective Aerodynamic Testing as assessed by Mean Glottal Flow Rate (MGFR)
Objective Aerodynamic Testing as assessed by Subglottal Pressure (SGP)
Objective Aerodynamic Testing as assessed by Vital Capacity (VC)
Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument
Quality of Life as assessed by Dyspnea Index (DI)
Quality of Life as assessed by Eating Assessment Tool (EAT-10)
Quality of Life as assessed by Vocal Fatigue Index (VFI)
Quality of Life as assessed by Voice Handicap Index-10 (VHI-10)
Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Silk Microparticle Filler Injection
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: Silk Microparticle Filler Injection · No Placebo Group · N/A
Silk Microparticle Filler Injection
Procedure
Experimental Group · 1 Intervention: Silk Microparticle Filler Injection · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
835 Previous Clinical Trials
1,432,637 Total Patients Enrolled
Sofregen Medical, Inc.Industry Sponsor
8 Previous Clinical Trials
351 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- 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.
- 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.
- 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.
- Brown, Joseph E., Christopher P. Gulka, Jodie E.M. Giordano, Maria P. Montero, Anh Hoang, and Thomas L. Carroll. 2019. “Injectable Silk Protein Microparticle-based Fillers: A Novel Material for Potential Use in Glottic Insufficiency”. Journal of Voice. Elsevier BV. doi:10.1016/j.jvoice.2018.01.017.
- Bellas, Evangelia, Bruce J.B. Panilaitis, Dean L. Glettig, Carl A. Kirker-Head, James J. Yoo, Kacey G. Marra, J. Peter Rubin, and David L. Kaplan. 2013. “Sustained Volume Retention in Vivo with Adipocyte and Lipoaspirate Seeded Silk Scaffolds”. Biomaterials. Elsevier BV. doi:10.1016/j.biomaterials.2013.01.058.
- Rosen, Clark A., Jackie Gartner-Schmidt, Roy Casiano, Timothy D. Anderson, Felicia Johnson, Marc Remacle, Robert T. Sataloff, et al.. 2009. “Vocal Fold Augmentation with Calcium Hydroxylapatite: Twelve-month Report”. The Laryngoscope. Wiley. doi:10.1002/lary.20126.
- Spector BC, Netterville JL, Billante C, Clary J, Reinisch L, Smith TL. Quality-of-life assessment in patients with unilateral vocal cord paralysis. Otolaryngol Head Neck Surg. 2001 Sep;125(3):176-82. doi: 10.1067/mhn.2001.117714.
- Michael Johns 2020. "Silk Protein Microparticle-based Filler for Injection Augmentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03790956.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer