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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
17
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.
Netherlands Cancer Institute: NKI
Amsterdam, Netherlands
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.
Time frame: 2 week
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.
Time frame: Baseline and 2 weeks
Voice Assessment - Highest volume
Highest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Time frame: Baseline and 2 weeks
Voice Assessment - Lowest Volume
Lowest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Time frame: Baseline and 2 weeks
Voice Assessment - Softness
Speaking as soft as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Time frame: Baseline and 2 weeks
Voice Assessment - Loudness
Speaking as loud as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis.
Time frame: 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.
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Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: Baseline, and week 52