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Allograft Adipose Injectable for Vocal Fold Paralysis

NCT04700566 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-02-06

No results posted yet for this study

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.

Conditions

  • Vocal Fold Palsy

Interventions

BIOLOGICAL

Renuva Allograft Adipose Matrix

Injection of Renuva Allograft adipose Matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2024-12-31
Completion
2025-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700566 on ClinicalTrials.gov