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NCT03864757
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
NA trial testing thyroplasty implant in Paralysis, Unilateral, Vocal Cord in 8 participants. Completed in 21 February 2019.
21 February 2019
Quick facts
| Lead sponsor | APrevent Biotech GmbH |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 8 |
| Start date | 5 July 2018 |
| Primary completion | 21 February 2019 |
| Estimated completion | 21 February 2019 |
| Sites | 1 location across Austria |
Drugs / interventions tested
- thyroplasty implant
Conditions studied
- Paralysis, Unilateral, Vocal Cord — all drugs for Paralysis, Unilateral, Vocal Cord →
Sponsor
APrevent Biotech GmbH
Who can join
Adults 18 to 80, any sex, with Paralysis, Unilateral, Vocal Cord. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03864757
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03864757 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by APrevent Biotech GmbH
- Last refreshed: 7 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03864757.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing