Paralysis, Unilateral, Vocal CordNCT03864757
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
A study testing thyroplasty implant in people with Paralysis, Unilateral, Vocal Cord, run by APrevent Biotech GmbH at 1 site in Austria.
Trial summary
The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paralysis, Unilateral, Vocal Cord
- What is being tested?
- thyroplasty implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteAustria
- Study dates
- 5 Jul 2018to 21 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- 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 and planned type I thyroplasty with conventional implant
- Ability to co-operate with the investigator and to comply with the requirements of the entire study
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
- Had medialization thyroplasty before
- Had injection medialization laryngoplasty in the past two years.
- Presence of structural vocal fold lesions such as polyp or nodules
- Status post total cordectomy
Show all 9Show fewer
- Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
- Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
- Severe coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP) - an Open-label, Non-randomized Pilot Study
The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.
- Conditions
- Paralysis, Unilateral, Vocal Cord
- Being tested
- thyroplasty implant
- Keywords
- unilateral vocal fold paralysis, type I thyroplasty
- 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.
thyroplasty implantDevice
Short-term implantation of thyroplasty implant, VOIS, and evaluation of voice quality and glottal closure. After evaluation, remove VOIS and perform medialization of vocal folds using conventional thyroplasty.
| Study group | Role | What they receive |
|---|---|---|
| UVFP correction surgery | Experimental | Short-term implantation of VOIS and evaluation of voice quality and glottal closure. Receives: Device: thyroplasty implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in voice quality by RBH-Scale
Roughness(R), Breathiness(B), Hoarseness(H) Scale will be rated on a 4-point severity scale (0, normal; 1, mild deviance; 2, moderate deviance; and 3, severe deviance).
Measured: pre-surgery, right after temporarily implantation
Change in Glottal closure by Södersten and Lindestad classification
Measured: pre-surgery, right after temporarily implantation
Change in maximum phonation time in seconds
The prolongation of a/a:/, for as long as possible after maximal inspiration, and at a spontaneous, comfortable pitch and loudness.
Measured: pre-surgery, right after temporarily implantation
Secondary outcomes (1)
Evaluation of surgical handling and device fitting using a VAS scale
Visual analogue scale(VAS) of Subjective Surgeon Satisfaction will be rated from 0 to 10. (0= not satisfied, 10= very satisfied)
Measured: right after temporarily implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start5 Jul 2018
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- APrevent Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Berit Schneider-Stickler, Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864757
- Sponsor's protocol ID
- APrevent-VOIS-Implant-001
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP) - an Open-label, Non-randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03864757
- Acronym / sponsor ID
- APrevent-VOIS-Implant-001
- Conditions
- Paralysis, Unilateral, Vocal Cord
- Keywords
- unilateral vocal fold paralysis, type I thyroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- APrevent Biotech GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 6 Mar 2019 (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.
The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UVFP correction surgery | Experimental | Device: thyroplasty implantShort-term implantation of VOIS and evaluation of voice quality and glottal closure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients between 18 and 80 years
- Diagnosed with permanent UVFP and insufficient glottal closure and planned type I thyroplasty with conventional implant
- Ability to co-operate with the investigator and to comply with the requirements of the entire study
Key exclusion criteria (9 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
- Had medialization thyroplasty before
- Had injection medialization laryngoplasty in the past two years.
- 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 |
|---|---|---|
| thyroplasty implantShort-term implantation of thyroplasty implant, VOIS, and evaluation of voice quality and glottal closure. After evaluation, remove VOIS and perform medialization of vocal folds using conventional thyroplasty. | Device | UVFP correction surgery |
Primary outcome
Change in voice quality by RBH-Scale
Time frame: pre-surgery, right after temporarily implantation
Roughness(R), Breathiness(B), Hoarseness(H) Scale will be rated on a 4-point severity scale (0, normal; 1, mild deviance; 2, moderate deviance; and 3, severe deviance).
Change in Glottal closure by Södersten and Lindestad classification
Time frame: pre-surgery, right after temporarily implantation
Change in maximum phonation time in seconds
Time frame: pre-surgery, right after temporarily implantation
The prolongation of a/a:/, for as long as possible after maximal inspiration, and at a spontaneous, comfortable pitch and loudness.
1 secondary outcome
Evaluation of surgical handling and device fitting using a VAS scale
Time frame: right after temporarily implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Paralysis, Unilateral, Vocal Cord
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
Enrolling by invitationObservational study
Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery
Unilateral Vocal Cord Paralysis, Vocal Cord Atrophy
Active, not recruiting
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
Bilateral Vocal Cord Paralysis
Recruiting
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Paralysis, Unilateral, Vocal Cord
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. This study is not recruiting at the moment.
Berit Schneider-Stickler, Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thyroplasty implant in people with Paralysis, Unilateral, Vocal Cord, run by APrevent Biotech GmbH at 1 site in Austria.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in voice quality by RBH-Scale (time frame: pre-surgery, right after temporarily implantation). The study lists 3 primary outcomes in all. 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 7 Mar 2019.