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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 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.

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

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What standards must be met to participate in this research?

"This clinical trial is seeking thirty participants between the ages of eighteen and eighty with laryngeal paralysis. To be eligible, applicants must display a palpable voice disorder (a GRBAS Grade ≥2 or VHI-30 score >33), comprehend the full purpose of this study including potential risks, and have the capability to comply with all requirements throughout its duration."

Answered by AI

Is there currently an open enrollment period for this investigation?

"Confirmed, clinicaltrials.gov details that this medical trial is still in need of participants since its initial posting on November 13th 2019 and most recent update on November 4th 2021. 30 individuals are desired to be recruited from a single facility."

Answered by AI

Is the age limit for applicants to this research study set at 75 years or above?

"Individuals between 18 and 80 years of age can take part in this research."

Answered by AI

How many participants can join the experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial is still enrolling participants, the original posting of which dates back to November 2019 and was most recently modified on November 2021. This study requires 30 human subjects from a single medical centre."

Answered by AI

Who else is applying?

What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I had temp vocal shots due to my vocal folds not closing properly. My voice still goes out often when singing.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
2019. "APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05119842.
~6 spots leftby Apr 2025
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