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

Study on the Safety and Effectiveness of APrevent® VOIS Implants for Treatment in Patients with Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open-Label, Non-Randomized Multicenter Study

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.

Study Overview

• Status: Recruiting
• Conditions: Paralysis, Unilateral, Vocal Cord
• Intervention / Treatment: Device: APrevent® VOIS-Implant

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Berit Schneider-Stickler, Prof; Phone Number: + 43-676-842 311 311; Email: office@med4com.at
• Study Contact Backup: Name: Matthias Leonhard, Dr; Phone Number: +43 1 404 00 - 33170; Email: matthias.leonhard@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna
    • Contact: Berit Schneider-Stickler, Prof
• Germany
  • Gera, Germany
    • Recruiting
    • SRH Wald-Klinikum Gera
  • Hamburg, Germany
    • Recruiting
    • University Medical Center
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic - Phoenix
      • Contact: Clinical Research Coordinator, RN; Phone Number: 480-574-1792; Email: Poletti.Samantha@mayo.edu
      • Contact: David Lott, MD
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Recruiting
      • Greater Baltimore Medical Center
      • Contact: Clinical Coordinator, Senior Speech-Language Pathologist, MM, MS, CCC-SLP; Phone Number: (443) 849-2087; Email: MBIDLACK@gbmc.org
      • Contact: Lee Akst, MD
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Not yet recruiting
      • Cleveland Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Research Coordinator; Phone Number: 713.704.4137; Email: Candace.Hernandez@uth.tmc.edu
      • Contact: Andrew Tritter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Treatment; Treatment with the VOIS Implant	Device: APrevent® VOIS-Implant; To compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in G-Score from GRBAS-Scale	Change in G-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation	7weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.	MPT will be measured in seconds using a digital stop clock. The patient will be asked to say a prolonged vowel "a" for as long as possible after maximal inspiration. The best out of three trials in seconds will be chosen for comparison.	7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
R-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.	R-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.	7 weeks
B-Score from GRBAS-Scale (range [0…3]) from before to 7 weeks after permanent APrevent® VOIS implantation	B-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.	7 weeks

Collaborators and Investigators

• Sponsor: APrevent Biotech GmbH
• Investigators: Principal Investigator: Matthias Leonhard, Dr, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 4, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Paralysis; Vocal Cord Paralysis
• Other Study ID Numbers: APrevent-VOIS-Implant-002

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: Yes
• product manufactured in and exported from the U.S.: No