An interventional study of APrevent® VOIS-Implant in Paralysis, Unilateral, Vocal Cord, sponsored by APrevent Biotech GmbH. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by APrevent Biotech GmbH · Not applicable, Interventional, and Treatment
Among 16 studies in Vocal Cord Paralysis with a site in United States — 7 open to participants now, 7 under way, 1 of them phase 3. Vocal Cord Paralysis · United States.
Among the 16 studies in Vocal Cord Paralysis with a site in United States, this one is the 7th largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2019, is one of 10 with no phase, and was the 10th registered.
61 studies on the registry are indexed under Vocal Cord Paralysis; 16 are open to participants now.
Browse Vocal Cord Paralysis studies →7 of the 16 studies in Vocal Cord Paralysis with a site in United States are open now. Recruiting first, the newest first:
Nemours Children's Clinic · Sites in United States
University of Virginia · Sites in United States
University of Virginia · Sites in United States
University of Southern California · Sites in United States
University of California, San Francisco · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 8 Vocal Cord Paralysis studies recruiting now, 5 (63%) set no upper age limit and 1 (13%) stop at 75 or younger; 1 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2019.
This study's planned enrollment of 30 is below the median of 39 across 43 interventional studies indexed under Vocal Cord Paralysis.
Median enrollment 40 across the 12 interventional studies, 275 across the 4 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 16 have an industry lead sponsor. The 10 most frequent:
APrevent Biotech GmbH is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
APrevent Biotech GmbH has 2 studies filed under Vocal Cord Paralysis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Vocal Cord Paralysis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with the VOIS Implant
Device: APrevent® VOIS-Implant
To compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.
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
R-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.
R-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.
Time frame: 7 weeks
B-Score from GRBAS-Scale (range [0…3]) from before to 7 weeks after permanent APrevent® VOIS implantation
B-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.
Time frame: 7 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2019 (actual). Primary completion is estimated for Sep 2025, 70 months after the start.
Of 20 interventional studies with no phase under Vocal Cord Paralysis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 70 months is above that.
How these figures are worked out, and which studies are left out of them.
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APrevent Biotech GmbH