Safety and Efficacy of Allograft Adipose Matrix Injectable for Glottal Insufficiency

HS-19-00876

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.

2022-05-16

2024-12-31

2025-07-01

Recruiting

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, prospective, interventional clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-02-06