Paralysis, Unilateral, Vocal Cord
Conditions
Keywords
unilateral vocal fold paralysis, type I thyroplasty
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.
Interventions
DEVICEthyroplasty implant
Short-term implantation of thyroplasty implant, VOIS, and evaluation of voice quality and glottal closure. After evaluation, remove VOIS and perform medialization of vocal folds using conventional thyroplasty.
Sponsors
APrevent Biotech GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in voice quality by RBH-Scale | 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 Glottal closure by Södersten and Lindestad classification | pre-surgery, right after temporarily implantation | — |
| Change in maximum phonation time in seconds | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of surgical handling and device fitting using a VAS scale | right after temporarily implantation | Visual analogue scale(VAS) of Subjective Surgeon Satisfaction will be rated from 0 to 10. (0= not satisfied, 10= very satisfied) |
Countries
Austria
Outcome results
None listed