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| Name | Class |
|---|---|
| The Netherlands Cancer Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Voice Prosthesis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 weeks |
| Voice Assessment - Highest volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michiel van den Brekel, Prof, MD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute: NKI | Amsterdam | 1066 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37656679 | Result | 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. |
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Highest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.
| Baseline and 2 weeks |
| Voice Assessment - Lowest Volume | Lowest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis. | Baseline and 2 weeks |
| Voice Assessment - Softness | Speaking as soft as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis. | Baseline and 2 weeks |
| Voice Assessment - Loudness | Speaking as loud as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis. | 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. | 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 | 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). | 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. | Baseline, and week 52 |