NCT05119842 · APrevent Biotech GmbH
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
What this study is about
This is a forward-looking, 2-part, multi-center, where both patients and doctors know the treatment given, non-randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Baltimore, Maryland
- Cleveland, Ohio
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2025 · Source of record for eligibility and locations