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

Paralysis, Unilateral, Vocal Cord Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864757
• Other study ID #: APrevent-VOIS-Implant-001
• Status: Completed
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: February 21, 2019

Study information

• Verified date: March 2019
• Source: APrevent Biotech GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Paralysis, Unilateral, Vocal Cord
• Vocal Cord Paralysis

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
APrevent Biotech GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Glottal closure by Södersten and Lindestad classification		pre-surgery, right after temporarily implantation
Primary	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	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