Paralysis, Unilateral, Vocal CordNCT05119842
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
A study testing APrevent® VOIS-Implant in people with Paralysis, Unilateral, Vocal Cord, run by APrevent Biotech GmbH at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Paralysis, Unilateral, Vocal Cord
- What is being tested?
- APrevent® VOIS-Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 13 Nov 2019to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Clinical Coordinator, Senior Speech-Language Pathologist, MM, MS, CCC-SLP, (443) 849-2087, MBIDLACK@gbmc.org
Lee Akst, MD
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44106
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Research Coordinator, 713.704.4137, Candace.Hernandez@uth.tmc.edu
Andrew Tritter, MD
- Recruiting
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
Clinical Research Coordinator, RN, 480-574-1792, Poletti.Samantha@mayo.edu
David Lott, MD
Germany2 sites, 2 recruiting
- Recruiting
SRH Wald-Klinikum Gera
Gera
- Recruiting
University Medical Center
Hamburg
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Berit Schneider-Stickler, Prof
About this study
Official title: Study on the Safety and Effectiveness of APrevent® VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open-Label, Non-Randomized Multicenter Study
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.
Read the detailed description
The APrevent® VOIS is intended to be permanently implanted during a type I thyroplasty in individuals suffering from permanent unilateral vocal fold paralysis of various etiologies. Four post-operative follow-up visits are planned: Week 1 (± 7 days), Week 7 (-7/+28 days), Month 6 (-14/+28 days) and Month 12 (-14/+28 days).
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
- Paralysis, Unilateral, Vocal Cord
- Being tested
- APrevent® VOIS-Implant
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APrevent® VOIS-ImplantDevice
To compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the VOIS Implant Receives: Device: APrevent® VOIS-Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in G-Score from GRBAS-Scale
Change in G-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation
Measured: 7weeks
Secondary outcomes (1)
Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.
MPT will be measured in seconds using a digital stop clock. The patient will be asked to say a prolonged vowel "a" for as long as possible after maximal inspiration. The best out of three trials in seconds will be chosen for comparison.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start13 Nov 2019
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralysis, Unilateral, Vocal CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will consist of two parts to assess safety, and effectiveness of the investigational device. 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- APrevent Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Leonhard, Dr, Principal investigator, Study principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119842
- Sponsor's protocol ID
- APrevent-VOIS-Implant-002
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2021
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Effectiveness of APrevent® VOIS Implants for Treatment in Patients With Unilateral Vocal Fold Paralysis (UVFP) - a Two-Part, Open-Label, Non-Randomized Multicenter Study
- ClinicalTrials.gov ID
- NCT05119842
- Acronym / sponsor ID
- APrevent-VOIS-Implant-002
- Conditions
- Paralysis, Unilateral, Vocal Cord
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- APrevent Biotech GmbHIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The APrevent® VOIS is intended to be permanently implanted during a type I thyroplasty in individuals suffering from permanent unilateral vocal fold paralysis of various etiologies. Four post-operative follow-up visits are planned: Week 1 (± 7 days), Week 7 (-7/+28 days), Month 6 (-14/+28 days) and Month 12 (-14/+28 days).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will consist of two parts to assess safety, and effectiveness of the investigational device. 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: APrevent® VOIS-ImplantTreatment with the VOIS Implant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APrevent® VOIS-ImplantTo compare the voice quality assessed by the change in G-Score from GRBAS-Scale between before and after permanent APrevent® VOIS implantation. | Device | Treatment |
Primary outcome
Change in G-Score from GRBAS-Scale
Time frame: 7weeks
Change in G-Score from GRBAS-Scale from before to 7 weeks after permanent APrevent® VOIS implantation
1 secondary outcome
Change in Maximum Phonation Time (MPT, unit seconds) from before to 7 weeks after permanent APrevent® VOIS implantation.
Time frame: 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Paralysis, Unilateral, Vocal Cord
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Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
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Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Leonhard, Dr principal investigator
Study principal investigator
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APrevent® VOIS-Implant in people with Paralysis, Unilateral, Vocal Cord, run by APrevent Biotech GmbH at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berit Schneider-Stickler, Prof (+ 43-676-842 311 311, office@med4com.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in G-Score from GRBAS-Scale (time frame: 7weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.