Actively Recruiting
Study on the Safety and Effectiveness of APrevent4 VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis - 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the APrevent4 VOIS Implant for treating patients with permanent unilateral vocal fold paralysis (UVFP). This prospective, two-part, multi-center, open-label, non-randomized clinical trial plans to enroll 30 patients. Part A focuses on safety assessment with sequential groups, followed by Part B which assesses device performance. The study is conducted by APrevent Biotech GmbH and aims to improve voice quality in affected patients. The investigational device, APrevent4 VOIS, is implanted permanently during a type I thyroplasty surgery in individuals with UVFP. The study includes two parts: Part A enrolls 8 patients in three groups with safety reviews after each group's first follow-up, and Part B assesses effectiveness after enrollment. There is no placebo or randomization. Four post-operative visits are scheduled at Week 1, Week 7, Month 6, and Month 12 to monitor participants. Participants will undergo assessments including voice quality measurement using the GRBAS Scale and Maximum Phonation Time. Follow-up visits involve clinical evaluations to monitor safety and performance of the implant. The primary outcome is the change in G-Score from the GRBAS Scale at 7 weeks post-implantation. Secondary outcomes include changes in maximum phonation time. Participants are followed for up to 12 months with evaluations to track progress and any side effects.
CONDITIONS
Brief 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 and insufficient glottal closure
- Significant voice disorder with Grade 2 or higher on the GRBAS Scale and Voice Handicap Index score above 33
- Ability to understand the study purpose, risks, and procedures
- Ability to cooperate with investigators and comply with study requirements
- Availability and willingness 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 put participant at 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 resorption timeframe
- Presence of vocal fold lesions such as polyps or nodules
- Presence of oropharyngeal or laryngeal tumors
- Diagnosed severe obstructive sleep apnea
- Previous total cordectomy or laryngeal framework surgery
- Status post tracheostomy
- Acute systemic infection at screening or shortly before surgery
- Severe non-laryngeal speech abnormalities
- Severe coagulopathy
- Pregnant, lactating, or planning pregnancy
- Bilateral Grade III-IV hypertrophic tonsils
- Poorly controlled diabetes with poor wound healing history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo permanent implantation of the APrevent® VOIS device during a type I thyroplasty surgery.
1 visit (in-person)
Duration - 12 months
Participants attend follow-up visits to monitor safety and effectiveness of the implant.
4 visits at Week 1 (±7 days), Week 7 (-7/+28 days), Month 6 (-14/+28 days), and Month 12 (-14/+28 days)
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
M
Matthias Leonhard, Dr
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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