Recruiting
Phase 3

Allograft Adipose

Sponsor:

University of Southern California

Code:

NCT04700566

Conditions

Vocal Fold Palsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Renuva Allograft Adipose Matrix

Study Details

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

Study ID

NCT04700566

Start date

May 16, 2022

Status verified date

Feb, 2023

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Injection of Renuva Allograft adipose matrix in vocal fold

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

Interventions

Renuva Allograft Adipose Matrix

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

Primary outcome measure

  • Number of adverse recorded in participants after injection [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Karla O'Dell, MD

18008722273karla.odell@med.usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Karla O'Dell

323-442-5790kodell@usc.edu

Michael Johns

3234425790michael.johna@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Feb 6, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-02-06.