drugset / Trial / NCT04700566

Allograft Adipose Injectable for Vocal Fold Paralysis

NCT04700566 ↗

Phase 3 Unknown 50 enrolled University of Southern California
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-05-16
Primary completion
2024-12-31
Completion
2025-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Renuva Other / unclassified — Other

Indications