Back to resultsAPrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
Primary Purpose
Paralysis, Unilateral, Vocal Cord
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
thyroplasty implant
Sponsored by
About this trial
This is an interventional device feasibility trial for Paralysis, Unilateral, Vocal Cord focused on measuring unilateral vocal fold paralysis, type I thyroplasty
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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UVFP correction surgery
Arm Description
Short-term implantation of VOIS and evaluation of voice quality and glottal closure.
Outcomes
Primary Outcome Measures
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).
Change in Glottal closure by Södersten and Lindestad classification
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03864757
Brief Title
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
Official Title
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP) - an Open-label, Non-randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
February 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
APrevent Biotech GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralysis, Unilateral, Vocal Cord
Keywords
unilateral vocal fold paralysis, type I thyroplasty
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UVFP correction surgery
Arm Type
Experimental
Arm Description
Short-term implantation of VOIS and evaluation of voice quality and glottal closure.
Intervention Type
Device
Intervention Name(s)
thyroplasty implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in voice quality by RBH-Scale
Description
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).
Time Frame
pre-surgery, right after temporarily implantation
Title
Change in Glottal closure by Södersten and Lindestad classification
Time Frame
pre-surgery, right after temporarily implantation
Title
Change in maximum phonation time in seconds
Description
The prolongation of a/a:/, for as long as possible after maximal inspiration, and at a spontaneous, comfortable pitch and loudness.
Time Frame
pre-surgery, right after temporarily implantation
Secondary Outcome Measure Information:
Title
Evaluation of surgical handling and device fitting using a VAS scale
Description
Visual analogue scale(VAS) of Subjective Surgeon Satisfaction will be rated from 0 to 10. (0= not satisfied, 10= very satisfied)
Time Frame
right after temporarily implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Schneider-Stickler, Dr.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
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