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

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

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.

Study Overview

• Status: Completed
• Conditions: Paralysis, Unilateral, Vocal Cord
• Intervention / Treatment: Device: thyroplasty implant

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UVFP correction surgery; Short-term implantation of VOIS and evaluation of voice quality and glottal closure.	Device: thyroplasty 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: APrevent Biotech GmbH
• Investigators: Principal Investigator: Berit Schneider-Stickler, Dr., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Actual): February 21, 2019
• Study Completion (Actual): February 21, 2019

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: unilateral vocal fold paralysis; type I thyroplasty
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Paralysis; Vocal Cord Paralysis
• Other Study ID Numbers: APrevent-VOIS-Implant-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No