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

Not Applicable

Completed

• Conditions: Paralysis, Unilateral, Vocal Cord
• Interventions: Device: thyroplasty implant

• Registration Number: NCT03864757
• Lead Sponsor: APrevent Biotech GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-05
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Study First Submitted: 2019-02-26
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-05
• Study First Posted: 2019-03-06
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UVFP correction surgery	thyroplasty implant	Short-term implantation of VOIS and evaluation of voice quality and glottal closure.

Primary Outcome Measures

Name	Time	Method
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 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.
Change in Glottal closure by Södersten and Lindestad classification	pre-surgery, right after temporarily implantation

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria