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.
- Oropharyngeal Dysphagia
- Unilateral Vocal Cord Paralysis
1 Primary · 14 Secondary · Reporting Duration: 12 months
1 Treatment Group
Silk Microparticle Filler Injection
1 of 1
100 Total Participants · 1 Treatment Group
Primary Treatment: Silk Microparticle Filler Injection · No Placebo Group · N/A
Who is running the clinical trial?
Age 18+ · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- 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
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