Laryngectomy
Conditions
Brief 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. 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.
Interventions
DEVICENew Voice Prosthesis
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.
Sponsors
The Netherlands Cancer Institute
Atos Medical AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient acceptability | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voice Assessment - Maximum phonation | Baseline and 2 weeks | Longest maximum phonation time in seconds out of 2 consecutive attempts. Assessed with current Voice prosthesis and the New Voice Prosthesis. |
| Voice Assessment - Highest volume | Baseline and 2 weeks | Highest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis. |
| Voice Assessment - Softness | Baseline and 2 weeks | Speaking as soft as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis. |
| Voice Assessment - Loudness | Baseline and 2 weeks | Speaking as loud as possible in decibels. Assessed with current Voice prosthesis and the New Voice Prosthesis. |
| Voice Assessment - Lowest Volume | Baseline and 2 weeks | Lowest volume in hertz. Assessed with current Voice prosthesis and the New Voice Prosthesis. |
| Quality of Life by EQ-5D-5L | Baseline and 2 weeks | 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 |
| Voice Handicap Index - 10 | Baseline and 2 weeks | 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). |
| Device life | Baseline, and week 52 | Device life of two previous Voice prosthesis and device life of the New Voice Prosthesis in the long-term part of study. |
| Voice Assessment - Glide tones | Baseline and 2 weeks | Successful completion of glide town, from low to high. Assessed with current Voice Prosthesis and the New Voice Prosthesis. |
Countries
Netherlands
Outcome results
None listed