NCT00661570终止不适用
Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Device Life Time
研究概览
简要总结
The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •total laryngectomy
- •use Provox2 voice prosthesis
- •at least two prior prosthesis changes
排除标准
- •current puncture problems (f. ex. infection)
结局指标
主要结局
Device Life Time
时间窗: at replacement of voice prosthesis (maximum 1 year)
Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.
次要结局
- Voice Quality(at 3 months or device change (whichever was first))
- Ease of Insertion(assessed immediately after insertion procedure)
- Reason for Replacement(At removal of prosthesis)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice ProsthesisTotal LaryngectomyNCT00743262Atos Medical AB15
已完成
不适用
Clinical Feasibility of a New Voice ProsthesisLaryngectomyNCT05079386Atos Medical AB17
已完成
不适用
Early clinical feasibility study of a new voice prosthesis: the Provox Vega HPNL-OMON50825Atos Medical AB20
已完成
不适用
Early clinical feasibility study of a new voice prosthesis: the Provox Vega HP'total laryngectomy' 'voice rehabilitation'10019190NL-OMON38672Atos Medical AB16
已完成
不适用
Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized PatientsTracheostomyNCT01976819Atos Medical AB16