Implant for treating vocal cord paralysis
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
Run by APrevent Biotech GmbH · NCT05119842 · Data updated 2026-11-12
This study is testing a new implant to see if it can safely help people with vocal cord paralysis speak better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | APrevent Biotech GmbH Industry-sponsored |
| Locations | 7 sites (Phoenix, Arizona and 6 other locations) |
| Status | Recruiting |
| Started | November 13, 2019 |
| Main results expected | September 2025 |
| Study ends | September 2026 |
| Registry record updated | February 6, 2025 |
| Trial ID | NCT05119842 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 diagnosed with permanent UVFP and experiencing significant voice disorders.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel, similar studies involving voice restoration techniques have shown promise, indicating potential for success.
Who can join: the full rules
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 it's running
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Mayo Clinic - Phoenix
Phoenix, Arizona, United States Recruiting -
Greater Baltimore Medical Center
Baltimore, Maryland, United States 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
Show 1 more location
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Cleveland Clinic
Cleveland, Ohio, United States Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating vocal fold motion in children on noninvasive ventilation
This study is testing if using ultrasound can safely check how well the vocal folds are moving in kids on noninvasive ventilation in the ICU compared to a standard method that might be riskier.
-
Treatment outcomes of selective laryngeal reinnervation for vocal fold paralysis
This study is testing if a specific surgery can help people with vocal fold paralysis regain their voice and reduce complications after not improving for at least six months.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.