APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study

APrevent Biotech

Status

Enrolling

Conditions

Paralysis, Unilateral, Vocal Cord

Treatments

Device: APrevent® VOIS-Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT05119842

APrevent-VOIS-Implant-002

Details and patient eligibility

About

This is a prospective, 2-part, multi-center, open-label, non-randomized clinical trial to assess safety and effectiveness of APrevent® VOIS Implants for the treatment of patients with Unilateral Vocal Fold Paralysis (UVFP). In total 30 evaluable patients are planned to be enrolled.

Full description

The APrevent® VOIS is intended to be permanently implanted during a type I thyroplasty in individuals suffering from permanent unilateral vocal fold paralysis of various etiologies. Four post-operative follow-up visits are planned: Week 1 (± 7 days), Week 7 (-7/+28 days), Month 6 (-14/+28 days) and Month 12 (-14/+28 days).

This 2-part study will consist of Part A to assess safety of the patients and the following Part B to assess the performance (effectiveness) of the investigational device. In Part A of the study 8 patients will be enrolled sequentially within three groups (N=1, N=2, N=5). After enrolment and 1st Follow-up Visit of each group, a Local Safety Board will review safety and study data. No preliminary/interim analysis of safety and effectiveness data will be performed before the end of the study.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female patients between 18 and 80 years
Diagnosed with permanent UVFP and insufficient glottal closure
A significant voice disorder as measured by perceptual rating (Grade ≥2 GRBAS Scale) and Voice Handicap Index (VHI-30 score >33)
Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
Ability to co-operate with the Investigator and to comply with the requirements of the entire study
Availability to volunteer for the entire study duration, willing to adhere to all protocol requirements and willing and able to give informed consent for participation

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
Bilateral vocal fold paralysis
Had injection medialization laryngoplasty with the injectable still being within the double length of the maximum resorption time frame as stated in their approval or as supported by literature.
Presence of structural vocal fold lesions such as polyp or nodules
Presence of oropharyngeal or laryngeal tumors
Patients with diagnosed severe obstructive sleep apnea (OSA)
Status post total cordectomy
Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
Status post tracheostomy
Presence of acute systemic infection at time of screening or shortly before surgery
Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
Severe coagulopathy
Females who are pregnant, lactating or planning pregnancy are excluded from the investigation
Patients with bil. Gr. III-IV hypertrophic tonsils
Diabetes mellitus with poor control and poor wound healing history