Silk Protein Microparticle-based Filler for Injection Augmentation

NCT03790956 | Completed

• 1 other identifier: APP-18-05229
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vocal fold paralysis; glottal insufficiency; vocal fold injection; augmentation; medialization; laryngoplasty; silk

Outcome Measures

Primary Outcomes (1)

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

  Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening.

  12 months

Secondary Outcomes (14)

• Quality of Life as assessed by Voice Handicap Index-10 (VHI-10)

  12 months

• Quality of Life as assessed by Vocal Fatigue Index (VFI)

  12 months

• Quality of Life as assessed by Dyspnea Index (DI)

  12 months

• Quality of Life as assessed by Eating Assessment Tool (EAT-10)

  12 months

• Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument

  12 months

Study Arms (1)

Silk Microparticle Filler Injection

EXPERIMENTAL

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

Procedure: Silk Microparticle Filler Injection

Interventions

Silk Microparticle Filler Injection PROCEDURE

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

Silk Microparticle Filler Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral vocal fold immobility with glottal insufficiency present for at least 2 weeks from onset
• Willingness to partake in study and follow-up as documented by signed informed consent

You may not qualify if:

• History of allergy/hypersensitivity to silk or silk containing products
• History of allergy/hypersensitivity to hyaluronic acid (HA) or HA containing products
• History of allergy/hypersensitivity to lidocaine or amide-based anesthetics
• History of an autoimmune condition
• Significant immunocompromised state (i.e. immunosuppression s/p transplantation)
• Pregnancy
• Active infection or inflammation in the larynx
• Comorbid known laryngeal conditions including but not limited to vocal fold scar, vocal tremor, laryngeal dystonia, etc. that would warrant other interventions for optimal treatment
• History of laryngeal surgery
• Life expectancy of less than 6 months

Sponsors & Collaborators

• University of Southern California: lead
• Sofregen Medical, Inc.: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (6)

• 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.

  PMID: 11555751 BACKGROUND

• Brown JE, Gulka CP, Giordano JEM, Montero MP, Hoang A, Carroll TL. Injectable Silk Protein Microparticle-based Fillers: A Novel Material for Potential Use in Glottic Insufficiency. J Voice. 2019 Sep;33(5):773-780. doi: 10.1016/j.jvoice.2018.01.017. Epub 2018 Mar 30.

  PMID: 29609905 BACKGROUND

• Etienne O, Schneider A, Kluge JA, Bellemin-Laponnaz C, Polidori C, Leisk GG, Kaplan DL, Garlick JA, Egles C. Soft tissue augmentation using silk gels: an in vitro and in vivo study. J Periodontol. 2009 Nov;80(11):1852-8. doi: 10.1902/jop.2009.090231.

  PMID: 19905955 BACKGROUND

• Bellas E, Panilaitis BJ, Glettig DL, Kirker-Head CA, Yoo JJ, Marra KG, Rubin JP, Kaplan DL. Sustained volume retention in vivo with adipocyte and lipoaspirate seeded silk scaffolds. Biomaterials. 2013 Apr;34(12):2960-8. doi: 10.1016/j.biomaterials.2013.01.058. Epub 2013 Jan 29.

  PMID: 23374707 BACKGROUND

• Kijanska M, Marmaras A, Hegglin A, Kurtcuoglu V, Giovanoli P, Lindenblatt N. In vivo characterization of the integration and vascularization of a silk-derived surgical scaffold. J Plast Reconstr Aesthet Surg. 2016 Aug;69(8):1141-50. doi: 10.1016/j.bjps.2016.01.017. Epub 2016 Feb 5.

  PMID: 26966076 BACKGROUND

• Rosen CA, Gartner-Schmidt J, Casiano R, Anderson TD, Johnson F, Remacle M, Sataloff RT, Abitbol J, Shaw G, Archer S, Zraick RI. Vocal fold augmentation with calcium hydroxylapatite: twelve-month report. Laryngoscope. 2009 May;119(5):1033-41. doi: 10.1002/lary.20126.

  PMID: 19274731 BACKGROUND

MeSH Terms

Conditions

Vocal Cord Paralysis; Dysphonia; Deglutition Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Otolaryngology-Head and Neck Surgery; Director, USC Voice Center

Model Details: Single vocal fold injection of study material with possible booster injection, and follow-up of 12 months post injection.

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: January 2, 2019
• Study Start: July 1, 2020
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (1)