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Clinical Trials in Germany / NCT05119842
Recruiting Not applicable

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

NCT05119842 · tracked via the Priya Life Science Germany tracker
Sponsor
APrevent Biotech GmbH
Phase
Not applicable
Started
2019-11-13
Last updated
2025-02-06

Condition(s) studied

Paralysis, Unilateral, Vocal Cord

Investigational drug(s) / intervention(s)

APrevent® VOIS-Implant

APrevent® VOIS-Implant: To compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Mayo Clinic - Phoenix Phoenix Arizona Recruiting
Greater Baltimore Medical Center Baltimore Maryland Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
The University of Texas Health Science Center at Houston Houston Texas Recruiting
Medical University of Vienna Vienna Austria Recruiting
SRH Wald-Klinikum Gera Gera Germany Recruiting
University Medical Center Hamburg Germany Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05119842 on ClinicalTrials.gov ↗ ← All trials in Germany