Early Clinical Feasibility Study of a New Voice Prosthesis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Laryngectomy
- Sponsor
- Atos Medical AB
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Patient acceptability
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Patient acceptability
Time Frame: 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 Outcomes
- Voice Assessment - Maximum phonation(Baseline and 2 weeks)
- Voice Assessment - Highest volume(Baseline and 2 weeks)
- Voice Assessment - Lowest Volume(Baseline and 2 weeks)
- Quality of Life by EQ-5D-5L(Baseline and 2 weeks)
- Voice Assessment - Glide tones(Baseline and 2 weeks)
- Device life(Baseline, and week 52)
- Voice Assessment - Softness(Baseline and 2 weeks)
- Voice Assessment - Loudness(Baseline and 2 weeks)
- Voice Handicap Index - 10(Baseline and 2 weeks)