APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Start Date
11/13/2019
Completion Date
9/1/2026
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.
Detailed Description
The APrevent® VOIS is intended to be permanently implanted during a type I thyroplasty in individuals suffering from permanent unilateral vocal fold paralysis of various etiologies. Four post-operative follow-up visits are planned: Week 1 (± 7 days), Week 7 (-7/+28 days), Month 6 (-14/+28 days) and Month 12 (-14/+28 days). This 2-part study will consist of Part A to assess safety of the patients and the following Part B to assess the performance (effectiveness) of the investigational device. In Part A of the study 8 patients will be enrolled sequentially within three groups (N=1, N=2, N=5). After enrolment and 1st Follow-up Visit of each group, a Local Safety Board will review safety and study data. No preliminary/interim analysis of safety and effectiveness data will be performed before the end of the study.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
APrevent® VOIS-Implant
Conditions
Locations
Mayo Clinic - Phoenix
Phoenix, Arizona 85054
United States
Greater Baltimore Medical Center
Baltimore, Maryland 21204
United States
Cleveland Clinic
Cleveland, Ohio 44106
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
Medical University of Vienna
Vienna,
Austria
SRH Wald-Klinikum Gera
Gera,
Germany
University Medical Center
Hamburg,
Germany