APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Recruiting
N/AInterventional Study
Paralysis, Unilateral, Vocal Cord
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
APrevent Biotech GmbH · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 ful…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.