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Implant
APrevent® VOIS-Implant for Vocal Cord Paralysis
N/A
Recruiting
Led By Matthias Leonhard, Dr
Research Sponsored by APrevent Biotech GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female patients between 18 and 80 years
Diagnosed with permanent UVFP and insufficient glottal closure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7weeks
Awards & highlights
Study Summary
This trial will test a new type of vocal cord implant to see if it is safe and effective for treating patients with paralysis of one vocal cord. Up to 30 patients will be enrolled.
Who is the study for?
This trial is for men and women aged 18-80 with permanent Unilateral Vocal Fold Paralysis (UVFP) causing significant voice issues. Participants must be able to follow the study plan, attend all sessions, and understand the risks. Exclusions include those with tracheostomy, recent laryngeal procedures, vocal fold lesions, severe infections or sleep apnea, tumors in throat areas, total cordectomy, severe speech disorders unrelated to UVFP.Check my eligibility
What is being tested?
The APrevent® VOIS Implant is being tested for safety and effectiveness in treating UVFP. The trial involves 30 patients across multiple centers who will receive this open-label treatment without randomization—meaning everyone gets the implant—and their progress will be closely monitored.See study design
What are the potential side effects?
While specific side effects are not listed here for APrevent® VOIS Implants, typical risks may include discomfort at the implant site, infection risk due to surgery or foreign body reaction from the implant itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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I have been diagnosed with permanent vocal fold paralysis and my vocal folds don't close properly.
Select...
I understand the study's purpose, risks, and side effects.
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I have a noticeable voice disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in G-Score from GRBAS-Scale
Secondary outcome measures
Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.
Other outcome measures
B-Score from GRBAS-Scale (range [0…3]) from before to 7 weeks after permanent APrevent® VOIS implantation
R-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with the VOIS Implant
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Who is running the clinical trial?
APrevent Biotech GmbHLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Matthias Leonhard, DrPrincipal InvestigatorStudy principal investigator
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, nor planning to become pregnant.I have been diagnosed with severe obstructive sleep apnea.I have a tumor in my throat or voice box.I have a severe blood clotting disorder.I do not have a current infection.I have had my entire vocal cord removed.I am between 18 and 80 years old.I have diabetes with poor control and a history of not healing well from wounds.You have a significant speech problem that is not related to the voice box.I had a voice box injection that is still effective.I have been diagnosed with permanent vocal fold paralysis and my vocal folds don't close properly.I have had a tracheostomy.I can follow the study's requirements and work with the research team.My tonsils are severely enlarged.I understand the study's purpose, risks, and side effects.I have a noticeable voice disorder.I have nodules or polyps on my vocal cords.I have had surgery to improve my voice before.I have a surgery planned that will require me to be put to sleep.Both sides of my voice box are paralyzed.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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