Injectable treatment for vocal fold paralysis using allograft adipose matrix
Safety and Efficacy of Allograft Adipose Matrix Injectable for Glottal Insufficiency
This study is testing if an injectable treatment called Renuva can help improve voice quality for people with vocal fold paralysis by providing a better and longer-lasting solution than current options.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04700566 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Renuva, an allograft adipose matrix, as an injectable treatment for vocal fold paralysis, specifically targeting glottic insufficiency. The study aims to assess the safety and efficacy of this injectable, which is designed to stimulate adipogenesis and integrate well with vocal fold tissues. By comparing Renuva to existing injectable options, the trial seeks to determine if it can provide a more effective and longer-lasting solution for patients suffering from vocal fold immobility. Participants will receive unilateral injections and will be monitored for outcomes related to voice quality and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unilateral vocal fold immobility and glottal insufficiency lasting at least two weeks.
Not a fit: Patients with known allergies to lidocaine, active laryngeal infections, or significant comorbid laryngeal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective long-term solution for patients with vocal fold paralysis.
How similar studies have performed: While various injectable materials have been used for vocal fold augmentation, the specific use of Renuva as an injectable for this purpose is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- University of Southern California — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Karla O'Dell, MD
- Email: karla.odell@med.usc.edu
- Phone: 18008722273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.