Actively Recruiting
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Led by APrevent Biotech GmbH · Updated on 2025-02-06
30
Participants Needed
7
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients between 18 and 80 years
- Diagnosed with permanent unilateral vocal fold paralysis (UVFP) and insufficient glottal closure
- Significant voice disorder with Grade 2 or higher on the GRBAS Scale and Voice Handicap Index (VHI-30) score above 33
- Ability to understand the study purpose, risks, and requirements
- Willingness and ability to cooperate and comply with all study procedures
- Availability to participate for the entire study duration and provide informed consent
You will not qualify if you...
- Any other significant disease or disorder that may increase risk or affect study results
- Scheduled elective surgery or procedures requiring general anesthesia during the study
- Bilateral vocal fold paralysis
- Recent injection medialization laryngoplasty within the approved resorption period
- Presence of structural vocal fold lesions such as polyps or nodules
- Presence of oropharyngeal or laryngeal tumors
- Diagnosed severe obstructive sleep apnea (OSA)
- History of total cordectomy
- Previous laryngeal framework surgery (any thyroplasty or arytenoid adduction)
- History of tracheostomy
- Acute systemic infection at screening or shortly before surgery
- Significant non-laryngeal speech abnormality (severe dysarthria)
- Severe coagulopathy
- Females pregnant, lactating, or planning pregnancy
- Bilateral Grade III-IV hypertrophic tonsils
- Poorly controlled diabetes mellitus with poor wound healing history
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
4
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
5
Medical University of Vienna
Vienna, Austria
Actively Recruiting
6
SRH Wald-Klinikum Gera
Gera, Germany
Actively Recruiting
7
University Medical Center
Hamburg, Germany
Actively Recruiting
Research Team
B
Berit Schneider-Stickler, Prof
CONTACT
M
Matthias Leonhard, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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