APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
NCT ID: NCT05119842
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2019-11-13
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
NCT04821739
STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures
NCT04835428
Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
NCT00726128
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
NCT02070484
Outcome Analysis for Minimally Invasive Spine Surgery and Navigation
NCT01751841
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This 2-part study will consist of Part A to assess safety of the patients and the following Part B to assess the performance (effectiveness) of the investigational device. In Part A of the study 8 patients will be enrolled sequentially within three groups (N=1, N=2, N=5). After enrolment and 1st Follow-up Visit of each group, a Local Safety Board will review safety and study data. No preliminary/interim analysis of safety and effectiveness data will be performed before the end of the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
Part A (Safety): In total 8 patients will be enrolled sequentially in three groups (N=1, N=2, N=5). An interval of at least 7 days between the groups will be left to allow the safety board to review individual patient's safety and demographic data. After completion of the first four patients and all three groups in Part A, an independent Data Safety Monitoring Board (DSMB) will recommend the initiation of study Part B based on the review of the safety data.
Part B: In Part B of the study, the remaining 22 patients of the study will be enrolled non-sequentially.
Part A and B (Effectiveness Population) will include: The part A patients will also be used for the confirmatory testing of the primary endpoint. At the end of the study safety of the investigational device will be assessed on patients of part A and B together.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Treatment with the 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
APrevent Biotech GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthias Leonhard, Dr
Role: PRINCIPAL_INVESTIGATOR
Study principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Cleveland Clinic
Cleveland, Ohio, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Medical University of Vienna
Vienna, , Austria
SRH Wald-Klinikum Gera
Gera, , Germany
University Medical Center
Hamburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Clinical Coordinator, Senior Speech-Language Pathologist, MM, MS, CCC-SLP
Role: primary
Berit Schneider-Stickler, Prof
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APrevent-VOIS-Implant-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.