APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP) - an Open-label, Non-randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in voice quality by RBH-Scale
研究概览
简要总结
The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between 18 and 80 years
- •Diagnosed with permanent UVFP and insufficient glottal closure and planned type I thyroplasty with conventional implant
- •Ability to co-operate with the investigator and to comply with the requirements of the entire study
排除标准
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation
- •Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation
- •Had medialization thyroplasty before
- •Had injection medialization laryngoplasty in the past two years.
- •Presence of structural vocal fold lesions such as polyp or nodules
- •Status post total cordectomy
- •Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
- •Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
- •Severe coagulopathy
研究组 & 干预措施
UVFP correction surgery
Short-term implantation of VOIS and evaluation of voice quality and glottal closure.
干预措施: thyroplasty implant (Device)
结局指标
主要结局
Change in voice quality by RBH-Scale
时间窗: pre-surgery, right after temporarily implantation
Roughness(R), Breathiness(B), Hoarseness(H) Scale will be rated on a 4-point severity scale (0, normal; 1, mild deviance; 2, moderate deviance; and 3, severe deviance).
Change in maximum phonation time in seconds
时间窗: pre-surgery, right after temporarily implantation
The prolongation of a/a:/, for as long as possible after maximal inspiration, and at a spontaneous, comfortable pitch and loudness.
Change in Glottal closure by Södersten and Lindestad classification
时间窗: pre-surgery, right after temporarily implantation
次要结局
- Evaluation of surgical handling and device fitting using a VAS scale(right after temporarily implantation)