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

Recruiting N/A Interventional Study
Paralysis, Unilateral, Vocal Cord
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
APrevent Biotech GmbH · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male and female patients between 18 and 80 years * Diagnosed with permanent UVFP and insufficient glottal closure * A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-30 score \>33) * Ability to comprehend the ful…
Contacts

Berit Schneider-Stickler, Prof

+ 43-676-842 311 311

office@med4com.at

CONTACT

Matthias Leonhard, Dr

+43 1 404 00 - 33170

matthias.leonhard@meduniwien.ac.at

CONTACT