APrevent® VOIS-Implant for Unilateral Vocal Cord Paralysis

Phase-Based Progress Estimates
Cleveland Clinic, Cleveland, OHUnilateral Vocal Cord ParalysisAPrevent® VOIS-Implant - Device
18 - 80
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Unilateral Vocal Cord Paralysis

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 7weeks

7 weeks
B-Score from GRBAS-Scale (range [0…3]) from before to 7 weeks after permanent APrevent® VOIS implantation
Change in Maximum Phonation Time (MPT, unit seconds) 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.
Change in G-Score from GRBAS-Scale

Trial Safety

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: APrevent® VOIS-Implant · No Placebo Group · N/A

Experimental Group · 1 Intervention: APrevent® VOIS-Implant · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7weeks

Who is running the clinical trial?

APrevent Biotech GmbHLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Matthias Leonhard, DrPrincipal InvestigatorStudy principal investigator

Eligibility Criteria

Age 18 - 80 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a condition called permanent UVFP that causes incomplete closure of your vocal cords.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.