Skip to main content
OpenTrials
Completed

NCT Number: NCT03864757

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Paralysis, Unilateral, Vocal Cord Cranial Nerve Diseases Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Vagus Nerve Diseases Vocal Cord Paralysis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thyroplasty implant

Device

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 outcomes

  1. Change in voice quality by RBH-Scale

    Time frame: 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).

  2. Change in Glottal closure by Södersten and Lindestad classification

    Time frame: pre-surgery, right after temporarily implantation

  3. Change in maximum phonation time in seconds

    Time frame: 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.

Secondary outcomes

  1. Evaluation of surgical handling and device fitting using a VAS scale

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

APrevent Biotech GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2019
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.