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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study 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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
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
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,228 Total Patients Enrolled
1 Trials studying Vocal Cord Paralysis
11 Patients Enrolled for Vocal Cord Paralysis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to lidocaine or similar numbing medicines.I have had surgery on my voice box.I have a known throat condition that needs different treatment.I am 18 years old or older.My voice box has been partly paralyzed for at least 2 weeks.I do not have a current infection or inflammation in my voice box.You are expected to live for less than 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Injection of Renuva Allograft adipose matrix in vocal fold
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned the utilization of Renuva Allograft adipose matrix injection for vocal fold treatment?
"There is extant clinical evidence affirming Injection of Renuva Allograft adipose matrix in vocal fold to be safe, thus it was scored a 3."
Answered by AI
Are there any slots left in this research trial?
"Affirmative. Clinicaltrials.gov presents evidence that this clinical examination is presently recruiting participants, with the initial posting of May 16th 2022 and most recent update occurring February 2nd 2023. There are 50 vacancies across 1 location for potential test subjects."
Answered by AI
How many participants are being recruited to join this medical experiment?
"Affirmative. According to clinicaltrials.gov, the trial was initially posted on May 16th 2022 and is now actively searching for participants. A total of 50 patients are required from one medical centre."
Answered by AI
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