Safety and Effectiveness of APrevent VOIS Implants for Treating Unilateral Vocal Fold Paralysis in Adults A Two-Part, Open-Label, Non-Randomized Multicenter Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the APrevent4 VOIS Implant for treating patients with permanent unilateral vocal fold paralysis UVFP. This prospective, two-part, multi-center, open-label, non-randomized clinical trial plans to enroll 30 patients. Part A focuses on safety assessment with sequential groups, followed by Part B which assesses device performance. The study is conducted by APrevent Biotech GmbH and aims to improve voice quality in affected patients. The investigational device, APrevent4 VOIS, is implanted permanently during a type I thyroplasty surgery in individuals with UVFP. The study includes two parts Part A enrolls 8 patients in three groups with safety reviews after each groups first follow-up, and Part B assesses effectiveness after enrollment. There is no placebo or randomization. Four post-operative visits are scheduled at Week 1, Week 7, Month 6, and Month 12 to monitor participants. Participants will undergo assessments including voice quality measurement using the GRBAS Scale and Maximum Phonation Time. Follow-up visits involve clinical evaluations to monitor safety and performance of the implant. The primary outcome is the change in G-Score from the GRBAS Scale at 7 weeks post-implantation. Secondary outcomes include changes in maximum phonation time. Participants are followed for up to 12 months with evaluations to track progress and any side effects.

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