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Allograft Adipose Injectable

Renuva Injection for Vocal Cord Paralysis

Phase 3
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Be older than 18 years old
Must not have
History of laryngeal surgery
Active infection or inflammation in the larynx (presence of acute laryngeal infection caused by bacteria/virus or fungus)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Summary

This trialwill see if Renuva, a filler used in cosmetic procedures, can be used as an injectable to treat vocal fold glottic insufficiency.

Who is the study for?
This trial is for adults over 18 with unilateral vocal fold immobility and glottic insufficiency lasting at least two weeks. Participants must consent to follow the study procedures. Pregnant individuals, those with active laryngeal infections or other complex laryngeal conditions, a life expectancy under six months, or allergies to certain anesthetics cannot join.Check my eligibility
What is being tested?
The trial is testing Renuva Allograft Adipose Matrix as an injectable treatment for glottic insufficiency caused by vocal fold paralysis. Renuva aims to integrate into the tissue without affecting its natural properties and may stimulate healing through growth factors.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects could include local reactions at the injection site such as swelling, pain, bruising; allergic reactions; and possibly voice changes due to incorrect placement or volume of filler.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery on my voice box.
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I do not have a current infection or inflammation in my voice box.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse recorded in participants after injection
Secondary outcome measures
Dyspnea Index as measured by patient questionnaire
Score on VALI - Voice Vibratory Assessment of laryngeal imaging
Voice outcomes as reported by patient questionnaire

Trial Design

1Treatment groups
Experimental Treatment
Group I: Injection of Renuva Allograft adipose matrix in vocal foldExperimental Treatment1 Intervention
Injection of Renuva Allograft Adipose matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Vocal Cord Paralysis, such as carbomethycellulose, hyaluronic acid, collagen derivatives, and calcium hydroxyapatite, work by providing structural support and volume to the vocal folds, thereby improving glottic closure and voice quality. These injectables aim to restore the fibroelastic properties of the vocal fold tissues without impairing their function. Renuva, an allograft adipose matrix, is being studied for its ability to stimulate adipogenesis using growth factors and collagen, which may offer a more integrated and natural augmentation of the vocal folds. This is crucial for patients as it could lead to better voice outcomes and reduced risk of adverse effects.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
919 Previous Clinical Trials
1,611,391 Total Patients Enrolled
1 Trials studying Vocal Cord Paralysis
11 Patients Enrolled for Vocal Cord Paralysis

Media Library

Renuva Allograft Adipose Matrix (Allograft Adipose Injectable) Clinical Trial Eligibility Overview. Trial Name: NCT04700566 — Phase 3
Vocal Cord Paralysis Research Study Groups: Injection of Renuva Allograft adipose matrix in vocal fold
Vocal Cord Paralysis Clinical Trial 2023: Renuva Allograft Adipose Matrix Highlights & Side Effects. Trial Name: NCT04700566 — Phase 3
Renuva Allograft Adipose Matrix (Allograft Adipose Injectable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04700566 — Phase 3
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