Allograft Adipose Injectable for Vocal Fold Paralysis

NCT04700566 | Unknown Phase 3 FDA Drug

• 1 other identifier: HS-19-00876
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Renuva is allograft adipose matrix commonly used as a filler in cosmetic procedures. The investigators are studying this material as an injectable in the vocal fold to treat glottic insufficiency. Currently, many products can be used as an injectable in the vocal fold to correct glottic insufficiency such as carbomethycellulose, hyaluronic acid, collagen derivatives and calcium hydroxyapatite amongst others. An ideal injectable would not impair the fibroelastic property of the vocal fold tissues and would integrate within the tissue of the vocal fold. Since Renuva has the property of stimulating adipogenesis by using growth factor and collagen, the investigators believe it could represent a good option in terms of safety and efficacy for vocal fold augmentation. This study will assess the safety and efficacy of Renuva as a vocal fold injectable to treat glottic insufficiency.

Conditions

Vocal Fold Palsy

Outcome Measures

Primary Outcomes (1)

• Number of adverse recorded in participants after injection

  Monitoring of adverse events during the study period for each participant receiving a vocal fold injection with Renuva

  18 months

Secondary Outcomes (3)

• Voice outcomes as reported by patient questionnaire

  18 months

• Score on VALI - Voice Vibratory Assessment of laryngeal imaging

  18 months

• Dyspnea Index as measured by patient questionnaire

  18 months

Study Arms (1)

Injection of Renuva Allograft adipose matrix in vocal fold

EXPERIMENTAL

Injection of Renuva Allograft Adipose matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency

Biological: Renuva Allograft Adipose Matrix

Interventions

Renuva Allograft Adipose Matrix BIOLOGICAL

Injection of Renuva Allograft adipose Matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency

Injection of Renuva Allograft adipose matrix in vocal fold

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• 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 lidocaine or amide-based anesthetics
• Pregnancy
• Active infection or inflammation in the larynx (presence of acute laryngeal infection caused by bacteria/virus or fungus)
• 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

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Vocal Cord Paralysis

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

Central Study Contacts

Karla O'Dell, MD

CONTACT

18008722273; karla.odell@med.usc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single arm, prospective, interventional clinical trial

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: May 16, 2022
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

US (1)