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APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study

NCT05119842 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-06

No results posted yet for this study

Summary

This is a prospective, 2-part, multi-center, open-label, non-randomized clinical trial to assess safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold Paralysis (UVFP). In total 30 evaluable patients are planned to be enrolled.

Conditions

  • Paralysis, Unilateral, Vocal Cord

Interventions

DEVICE

APrevent® VOIS-Implant

To compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.

Sponsors & Collaborators

  • APrevent Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Matthias Leonhard, Dr · Study principal investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2025-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States
  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05119842 on ClinicalTrials.gov