Clinical Feasibility of a New Voice Prosthesis
- Conditions
- Laryngectomy
- Interventions
- Device: New Voice Prosthesis
- Registration Number
- NCT05079386
- Lead Sponsor
- Atos Medical AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description New Voice Prosthesis New Voice Prosthesis 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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 - 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 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.
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 - 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.
Trial Locations
- Locations (1)
Netherlands Cancer Institute: NKI
🇳🇱Amsterdam, Netherlands