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

Study Overview
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Brief Summary
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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.

Official Title
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APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP) - an Open-label, Non-randomized Pilot Study

Conditions
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Paralysis, Unilateral, Vocal Cord

Intervention / Treatment
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* Device: thyroplasty implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UVFP correction surgery<br>Short-term implantation of VOIS and evaluation of voice quality and glottal closure. | Device: thyroplasty implant<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in voice quality by RBH-Scale | 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). | pre-surgery, right after temporarily implantation | 
| Change in Glottal closure by Södersten and Lindestad classification |  | pre-surgery, right after temporarily implantation | 
| Change in maximum phonation time in seconds | The prolongation of a/a:/, for as long as possible after maximal inspiration, and at a spontaneous, comfortable pitch and loudness. | pre-surgery, right after temporarily implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of surgical handling and device fitting using a VAS scale | Visual analogue scale(VAS) of Subjective Surgeon Satisfaction will be rated from 0 to 10. (0= not satisfied, 10= very satisfied) | right after temporarily implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unilateral vocal fold paralysis, type I thyroplasty