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

NCT ID: NCT03864757

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-05
• Study Completion Date: 2019-02-21

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.

Conditions

Paralysis, Unilateral, Vocal Cord

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

UVFP correction surgery

Short-term implantation of VOIS and evaluation of voice quality and glottal closure.

Group Type: EXPERIMENTAL

thyroplasty implant

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

APrevent Biotech GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berit Schneider-Stickler, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

APrevent-VOIS-Implant-001

Identifier Type: -

Identifier Source: org_study_id