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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

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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7weeks

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

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

0 / 17Eligibility criteria met

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

Unilateral Vocal Cord Paralysis Research Study Groups: Treatment

Unilateral 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 Jul 2025

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