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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
To compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
RECRUITINGGreater Baltimore Medical Center
Baltimore, Maryland, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
Change in G-Score from GRBAS-Scale
Change in G-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation
Time frame: 7weeks
Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.
MPT will be measured in seconds using a digital stop clock. The patient will be asked to say a prolonged vowel "a" for as long as possible after maximal inspiration. The best out of three trials in seconds will be chosen for comparison.
Time frame: 7 weeks
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGMedical University of Vienna
Vienna, Austria
RECRUITINGSRH Wald-Klinikum Gera
Gera, Germany
RECRUITINGUniversity Medical Center
Hamburg, Germany
RECRUITING