APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP) - an Open-label, Non-randomized Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Paralysis, Unilateral, Vocal Cord
- Sponsor
- APrevent Biotech GmbH
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in voice quality by RBH-Scale
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 implantation and then after permanent existing product implantation.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in voice quality by RBH-Scale
Time Frame: pre-surgery, right after temporarily implantation
Roughness(R), Breathiness(B), Hoarseness(H) Scale will be rated on a 4-point severity scale (0, normal; 1, mild deviance; 2, moderate deviance; and 3, severe deviance).
Change in maximum phonation time in seconds
Time Frame: pre-surgery, right after temporarily implantation
The prolongation of a/a:/, for as long as possible after maximal inspiration, and at a spontaneous, comfortable pitch and loudness.
Change in Glottal closure by Södersten and Lindestad classification
Time Frame: pre-surgery, right after temporarily implantation
Secondary Outcomes
- Evaluation of surgical handling and device fitting using a VAS scale(right after temporarily implantation)