AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - 80 YearsAllAPrevent Biotech GmbH
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

  • APrevent® VOIS-Implant
📍

Where

7 sites
Mayo Clinic - Phoenix
Phoenix, United States
Greater Baltimore Medical Center
Baltimore, United States
Cleveland Clinic
Cleveland, United States
The University of Texas Health Science Center at Houston
Houston, United States
Medical University of Vienna
Vienna, Austria
SRH Wald-Klinikum Gera
Gera, Germany
University Medical Center
Hamburg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy