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NCT05119842 · ClinicalTrials.gov registry record · NA
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
A NA study of Paralysis, Unilateral, Vocal Cord, sponsored by APrevent Biotech.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 7
- Study locations
NCT05119842: Recruiting NA study of Paralysis, Unilateral, Vocal Cord, sponsored by APrevent Biotech.
NCT05119842 is a NA study of Paralysis, Unilateral, Vocal Cord that is actively recruiting participants, run by APrevent Biotech. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05119842, a NA study of Paralysis, Unilateral, Vocal Cord, is actively recruiting participants, sponsored by APrevent Biotech.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Change in G-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation
Conditions Studied
Interventions
- DEVICE APrevent® VOIS-Implant
Study Locations (7)
Other
- Medical University of Vienna - Vienna
- SRH Wald-Klinikum Gera - Gera
- University Medical Center - Hamburg
Arizona
- Mayo Clinic - Phoenix - Phoenix
Maryland
- Greater Baltimore Medical Center - Baltimore
Ohio
- Cleveland Clinic - Cleveland
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT05119842 shows while recruiting
NCT05119842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Paralysis, Unilateral, Vocal Cord appearing as the primary indexed condition, and to 1 intervention - of which APrevent® VOIS-Implant is the first listed.
NCT05119842 lists 7 locations in 5 states (Other, Arizona, Maryland).
Frequently Asked Questions
What is clinical trial NCT05119842 about?
NCT05119842 is a clinical study titled "APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study". 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.
What is the current status of trial NCT05119842?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2019-11-13. Estimated completion is 2026-09.
What conditions does trial NCT05119842 study?
This clinical trial studies the following conditions: Paralysis, Unilateral, Vocal Cord.
What interventions are being tested in trial NCT05119842?
The interventions under investigation include: APrevent® VOIS-Implant (DEVICE).
Who is sponsoring clinical trial NCT05119842?
This trial is sponsored by APrevent Biotech, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05119842 being conducted?
This trial has 7 study locations across Arizona, Maryland, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05119842's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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