Early Clinical Feasibility Study of a New Voice Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Patient acceptability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient acceptability
时间窗: 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.
次要结局
- 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)