NCT04700566|UnknownPhase 3FDA Drug
Allograft Adipose Injectable for Vocal Fold Paralysis
Safety and Efficacy of Allograft Adipose Matrix Injectable for Glottal Insufficiency
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Sponsor study identifier
interventional
50
1 country
1
Study Start
May 16, 2022
Actual (reported)Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2021
Actual (reported)January 8, 2021
Actual (reported)May 16, 2022
Actual (reported)December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of adverse recorded in participants after injection
Monitoring of adverse events during the study period for each participant receiving a vocal fold injection with Renuva
18 months
Voice outcomes as reported by patient questionnaire
18 months
Score on VALI - Voice Vibratory Assessment of laryngeal imaging
18 months
Dyspnea Index as measured by patient questionnaire
18 months
Injection of Renuva Allograft Adipose matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency
Injection of Renuva Allograft adipose Matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Southern California
Los Angeles, California, 90033, United States
Santa Maria C, Shuman EA, Bensoussan YE, Bhatt NK, Morgan J, Rodman J, La Forest K, Timmons-Sund L, Johns MM 3rd, O'Dell K. Prospective Short-Term Outcomes of Allograft Adipose Matrix (AAM) for Vocal Fold Augmentation. Laryngoscope. 2026 Apr;136(4):1808-1814. doi: 10.1002/lary.70240. Epub 2025 Nov 6.
First Submitted
January 4, 2021
First Posted
January 8, 2021
Study Start
May 16, 2022
Actual (reported)Primary Completion
December 31, 2024
Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 6, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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