APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)

APrevent Biotech

Status

Completed

Conditions

Paralysis, Unilateral, Vocal Cord

Treatments

Device: thyroplasty implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT03864757

APrevent-VOIS-Implant-001

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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