Clinical Feasibility of a New Voice Prosthesis

Study Overview
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Brief Summary
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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.

Official Title
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Early Clinical Feasibility Study of a New Voice Prosthesis

Conditions
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Laryngectomy

Intervention / Treatment
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* Device: New Voice Prosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Voice Prosthesis<br>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. | Device: New Voice Prosthesis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |