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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
Must not have
Females who are pregnant, lactating or planning pregnancy are excluded from the investigation
Patients with diagnosed severe obstructive sleep apnea (OSA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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I understand the study's purpose, risks, and side effects.
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I have a noticeable voice disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, nor planning to become pregnant.
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I have been diagnosed with severe obstructive sleep apnea.
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I have a tumor in my throat or voice box.
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I have a severe blood clotting disorder.
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I do not have a current infection.
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I have had my entire vocal cord removed.
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I have diabetes with poor control and a history of not healing well from wounds.
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I have had a tracheostomy.
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My tonsils are severely enlarged.
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I have nodules or polyps on my vocal cords.
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I have had surgery to improve my voice before.
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I have a surgery planned that will require me to be put to sleep.
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Both sides of my voice box are paralyzed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in G-Score from GRBAS-Scale
Secondary study objectives
Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.
Other study objectives
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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with the VOIS Implant

Find a Location

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

APrevent® VOIS-Implant (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05119842 — N/A
Vocal cord paralysis Research Study Groups: Treatment
Vocal cord paralysis Clinical Trial 2023: APrevent® VOIS-Implant Highlights & Side Effects. Trial Name: NCT05119842 — N/A
APrevent® VOIS-Implant (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05119842 — N/A
~5 spots leftby Jan 2026
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