LaryngectomyNCT05079386
Clinical Feasibility of a New Voice Prosthesis
A study testing New Voice Prosthesis in people with Laryngectomy, run by Atos Medical AB at 1 site in Netherlands.
Trial summary
The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngectomy
- What is being tested?
- New Voice Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Jan 2022to 27 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laryngectomized patients using either the Provox Vega 22.5 or the Provox ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
- 18 years and older
Who cannot join
- Current tracheoesophageal puncture problems such as enlarged puncture or infection
- Active recurrent or metastatic disease (medical deterioration)
- The use of ActiValve Strong/XtraStrong or XtraSeal
- Unable to understand the Patient Information and/or unable to give Informed Consent
- The previous 2 VPs had a device lifetime > 12 months
- History of oral resections negatively affecting speech
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Clinical Feasibility Study of a New Voice Prosthesis
The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.
- Conditions
- Laryngectomy
- Being tested
- New Voice Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Voice ProsthesisDevice
Replacement of the current prosthesis with the experimental device and use the New Voice Prosthesis for the duration of two weeks with the option of leaving the device in situ until replaced for device failure or other reason, with a maximum of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| New Voice Prosthesis | Experimental | Patients will use the New Voice Prosthesis for two weeks to investigate short term feasibility and explore limitations and advantages. If the patient wishes to leave the New Voice Prosthesis in situ, this will be allowed under the condition that the subject agrees to remain in the study and report (adverse) events on an ongoing basis, until the device is removed after a maximum of 12 months. Receives: Device: New Voice Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient acceptability
Patient recorded acceptability of the voice prosthesis based on study specific questionnaires covering: 1) Experienced stickiness, 2) Effort to speak and 3) maintenance of voice prosthesis. Assessed by Yes/No and multiple choice questions.
Measured: 2 week
Secondary outcomes (9)
Voice Assessment - Maximum phonation
Longest maximum phonation time in seconds out of 2 consecutive attempts. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Measured: Baseline and 2 weeks
Voice Assessment - Highest volume
Highest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Measured: Baseline and 2 weeks
Voice Assessment - Lowest Volume
Lowest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Measured: Baseline and 2 weeks
Voice Assessment - Softness
Speaking as soft as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Measured: Baseline and 2 weeks
Voice Assessment - Loudness
Speaking as loud as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Measured: Baseline and 2 weeks
Voice Assessment - Glide tones
Successful completion of glide town, from low to high. Assessed with current Voice Prosthesis and the New Voice Prosthesis.
Measured: Baseline and 2 weeks
Quality of Life by EQ-5D-5L
Patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility
Measured: Baseline and 2 weeks
Voice Handicap Index - 10
Validated tool to assess Voice handicap. Statements on participant's voice quality and effect on social life are assessed by a five-point Likert-scale, ranged from 0-4, with high scores indicating more handicap (0 = Never, 4 = Always).
Measured: Baseline and 2 weeks
Device life
Device life of two previous Voice prosthesis and device life of the New Voice Prosthesis in the long-term part of study.
Measured: Baseline, and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start7 Jan 2022
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaryngectomyStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atos Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Netherlands Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Michiel van den Brekel, Prof, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079386
- Sponsor's protocol ID
- N21VEG
- Status last verified
- Sep 2023
- First submitted
- 4 Oct 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heirman AN, Tellman RS, van der Molen L, van Son R, van Sluis K, Halmos GB, Van den Brekel MWM, Dirven R. The acceptance and voice quality of a new voice prosthesis 'Vega High performance' - a feasibility study. Acta Otolaryngol. 2023 Aug;143(8):721-729. doi: 10.1080/00016489.2023.2241876. Epub 2023 Sep 1.
PubMed 37656679
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Feasibility Study of a New Voice Prosthesis
- ClinicalTrials.gov ID
- NCT05079386
- Acronym / sponsor ID
- N21VEG
- Conditions
- Laryngectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Atos Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- The Netherlands Cancer Institute
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 15 Oct 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.
The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Voice Prosthesis | Experimental | Device: New Voice ProsthesisPatients will use the New Voice Prosthesis for two weeks to investigate short term feasibility and explore limitations and advantages. If the patient wishes to leave the New Voice Prosthesis in situ, this will be allowed under the condition that the subject agrees to remain in the study and report (adverse) events on an ongoing basis, until the device is removed after a maximum of 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Laryngectomized patients using either the Provox Vega 22.5 or the Provox ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
- 18 years and older
Key exclusion criteria (6 listed)
- Current tracheoesophageal puncture problems such as enlarged puncture or infection
- Active recurrent or metastatic disease (medical deterioration)
- The use of ActiValve Strong/XtraStrong or XtraSeal
- Unable to understand the Patient Information and/or unable to give Informed Consent
- The previous 2 VPs had a device lifetime > 12 months
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 |
|---|---|---|
| New Voice ProsthesisReplacement of the current prosthesis with the experimental device and use the New Voice Prosthesis for the duration of two weeks with the option of leaving the device in situ until replaced for device failure or other reason, with a maximum of 12 months. | Device | New Voice Prosthesis |
Primary outcome
Patient acceptability
Time frame: 2 week
Patient recorded acceptability of the voice prosthesis based on study specific questionnaires covering: 1) Experienced stickiness, 2) Effort to speak and 3) maintenance of voice prosthesis. Assessed by Yes/No and multiple choice questions.
9 secondary outcomes
Voice Assessment - Maximum phonation
Time frame: Baseline and 2 weeks
Voice Assessment - Highest volume
Time frame: Baseline and 2 weeks
Voice Assessment - Lowest Volume
Time frame: Baseline and 2 weeks
Voice Assessment - Softness
Time frame: Baseline and 2 weeks
Voice Assessment - Loudness
Time frame: Baseline and 2 weeks
Voice Assessment - Glide tones
Time frame: Baseline and 2 weeks
Quality of Life by EQ-5D-5L
Time frame: Baseline and 2 weeks
Voice Handicap Index - 10
Time frame: Baseline and 2 weeks
Device life
Time frame: Baseline, and week 52
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 13 Sep 2023.
- Results publication: PubMed 37656679Heirman AN, Tellman RS, van der Molen L, van Son R, van Sluis K, Halmos GB, Van den Brekel MWM, Dirven R. The acceptance and voice quality of a new voice prosthesis 'Vega High performance' - a feasibility study. Acta Otolaryngol. 2023 Aug;143(8):721-729. doi: 10.1080/00016489.2023.2241876. Epub 2023 Sep 1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michiel van den Brekel, Prof, MD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Voice Prosthesis in people with Laryngectomy, run by Atos Medical AB at 1 site in Netherlands.
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 2 inclusion and 6 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 13 Sep 2023. 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 Netherlands. 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?
Patient acceptability (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079386, which also lists 1 linked publication.
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 13 Sep 2023.