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NCT03864757

APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)

Completed NA Last updated 7 March 2019
What this trial tests

NA trial testing thyroplasty implant in Paralysis, Unilateral, Vocal Cord in 8 participants. Completed in 21 February 2019.

Timeline
5 July 2018
Primary endpoint
21 February 2019
21 February 2019

Quick facts

Lead sponsorAPrevent Biotech GmbH
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment8
Start date5 July 2018
Primary completion21 February 2019
Estimated completion21 February 2019
Sites1 location across Austria

Drugs / interventions tested

Conditions studied

Sponsor

APrevent Biotech GmbH

Who can join

Adults 18 to 80, any sex, with Paralysis, Unilateral, Vocal Cord. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03864757.

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