RECRUITING

Allograft Adipose Injectable for Vocal Fold Paralysis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Efficacy of Allograft Adipose Matrix Injectable for Glottal Insufficiency

Quick Facts

Study Start:2022-05-16
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04700566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Age ≥ 18 years old
  2. * Unilateral vocal fold immobility with glottal insufficiency present for at least 2 weeks from onset
  3. * Willingness to partake in study and follow-up as documented by signed informed consent
  1. * History of allergy/hypersensitivity to lidocaine or amide-based anesthetics
  2. * Pregnancy
  3. * Active infection or inflammation in the larynx (presence of acute laryngeal infection caused by bacteria/virus or fungus)
  4. * 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
  5. * History of laryngeal surgery
  6. * Life expectancy of less than 6 months

Contacts and Locations

Study Contact

Karla O'Dell, MD
CONTACT
18008722273
karla.odell@med.usc.edu

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-16
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2022-05-16
Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Vocal Fold Palsy