Status:
COMPLETED
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
Lead Sponsor:
APrevent Biotech GmbH
Conditions:
Paralysis, Unilateral, Vocal Cord
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Male and female patients between 18 and 80 years
- Diagnosed with permanent UVFP and insufficient glottal closure and planned type I thyroplasty with conventional implant
- Ability to co-operate with the investigator and to comply with the requirements of the entire study
Exclusion
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation
- Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation
- Had medialization thyroplasty before
- Had injection medialization laryngoplasty in the past two years.
- Presence of structural vocal fold lesions such as polyp or nodules
- Status post total cordectomy
- Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
- Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
- Severe coagulopathy
Key Trial Info
Start Date :
July 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03864757
Start Date
July 5 2018
End Date
February 21 2019
Last Update
March 7 2019
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria