Implant for treating vocal cord paralysis
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 study is testing a new implant to see if it can safely help people with vocal cord paralysis speak better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | APrevent Biotech GmbH Industry-sponsored |
| Locations | 7 sites (Phoenix, Arizona and 6 other locations) |
| Trial ID | NCT05119842 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the APrevent® VOIS Implant for patients with Unilateral Vocal Fold Paralysis (UVFP). It consists of two parts: Part A focuses on safety assessment with a sequential enrollment of 8 patients, while Part B assesses the performance of the implant. Participants will undergo a type I thyroplasty for permanent implantation, followed by four scheduled post-operative follow-up visits to monitor outcomes over a year.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with permanent UVFP and experiencing significant voice disorders.
Not a fit: Patients with other significant diseases or disorders that may affect their participation or the study's outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve voice quality and communication abilities for patients suffering from vocal cord paralysis.
How similar studies have performed: While this approach is novel, similar studies involving voice restoration techniques have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 6 other locations
- Mayo Clinic - Phoenix — Phoenix, Arizona, United States (Recruiting)
- Greater Baltimore Medical Center — Baltimore, Maryland, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Not_yet_recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
- Medical University of Vienna — Vienna, Austria (Recruiting)
- SRH Wald-Klinikum Gera — Gera, Germany (Recruiting)
- University Medical Center — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Matthias Leonhard, Dr — Study principal investigator
- Study coordinator: Berit Schneider-Stickler, Prof
- Email: office@med4com.at
- Phone: + 43-676-842 311 311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.