Clinical trial NCT05119842: APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paralysis, Unilateral, Vocal Cord
Lead sponsor: APrevent Biotech GmbH
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will consist of two parts to assess safety, and effectiveness of the investigational device.

Part A (Safety): In total 8 patients will be enrolled sequentially in three groups (N=1, N=2, N=5). An interval of at least 7 days between the groups will be left to allow the safety board to review individual patient's safety and demographic data. After completion of the first four patients and all three groups in Part A, an independent Data Safety Monitoring Board (DSMB) will recommend the initiation of study Part B based on the review of the safety data.

Part B: In Part B of the study, the remaining 22 patients of the study will be enrolled non-sequentially.

Part A and B (Effectiveness Population) will include: The part A patients will also be used for the confirmatory testing of the primary endpoint. At the end of the study safety of the investigational device will be assessed on patients of part A and B together.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in G-Score from GRBAS-Scale
timeFrame: 7weeks
Secondary outcomes:
measure: Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.
timeFrame: 7 weeks
Other outcomes:
measure: R-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation.
timeFrame: 7 weeks
measure: B-Score from GRBAS-Scale (range [0…3]) from before to 7 weeks after permanent APrevent® VOIS implantation
timeFrame: 7 weeks
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic - Phoenix
state: Arizona
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera
city: Hamburg
country: Germany
facility: University Medical Center
Study officials:
affiliation: Study principal investigator
name: Matthias Leonhard, Dr
role: PRINCIPAL_INVESTIGATOR
References: