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

Paralysis, Unilateral, Vocal Cord Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05119842
• Other study ID #: APrevent-VOIS-Implant-002
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2019
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: APrevent Biotech GmbH
• Contact: Berit Schneider-Stickler, Prof
• Phone: + 43-676-842 311 311
• Email: office[@]med4com.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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

• 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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Germany	SRH Wald-Klinikum Gera	Gera
Germany	University Medical Center	Hamburg
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
APrevent Biotech GmbH

Countries where clinical trial is conducted

United States,  Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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