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

Launched by APREVENT BIOTECH GMBH · Nov 4, 2021

Keywords

ClinConnect Summary

The APrevent-VOIS-Implant-002 clinical trial is studying a new treatment using APrevent® VOIS Implants for patients with Unilateral Vocal Fold Paralysis (UVFP), a condition that causes one vocal cord to be unable to move properly, leading to significant voice problems. This study aims to assess the safety and effectiveness of these implants in improving voice quality. The trial is open to both men and women aged 18 to 80 who have been diagnosed with permanent UVFP and have experienced a notable voice disorder. To participate, individuals must also be able to understand the study's purpose and agree to follow the study's requirements.

Participants can expect to be part of a two-part study that includes close monitoring and follow-up to evaluate how well the treatment works and if there are any side effects. While the trial is currently recruiting patients, there are certain health conditions that could prevent someone from joining, such as having other significant health issues, certain types of previous surgeries on the voice box, or severe sleep apnea. It's important for potential participants to discuss their health history with the study team to see if they qualify.

Gender

ALL

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