APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- APrevent Biotech GmbH
- Study ID
- NCT05119842
- Status
- Recruiting
Conditions
- Paralysis, Unilateral, Vocal Cord
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Accepted
Interventions
- APrevent® VOIS-Implant — DEVICETo compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.
Study Details
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.
Key Dates
- Start date
- Nov 13, 2019
- Status verified
- Feb 2025
- Primary completion
- Sep 30, 2025
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TreatmentTreatment with the VOIS Implant
Primary Outcome Measure
Change in G-Score from GRBAS-Scale [ Time Frame: 7weeks ]
Central Contacts
- Berit Schneider-Stickler, Prof+ 43-676-842 311 311
- Matthias Leonhard, Dr+43 1 404 00 - 33170
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic - Phoenix | Phoenix | Arizona | 85054 | David Lott, MD (PRINCIPAL_INVESTIGATOR) |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | Clinical Coordinator, Senior Speech-Language Pathologist, MM, MS, CCC-SLP (443) 849-2087 Lee Akst, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44106 | - |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Andrew Tritter, MD (PRINCIPAL_INVESTIGATOR) |