NCT05482815进行中（未招募）不适用
Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy: a Prospective, Multicenter, Self-controlled Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Change in pronunciation effect (subjective auditory assessment)
研究概览
简要总结
The objective of the study is to evaluate the clinical safety and efficacy of voice prosthesis for voice reconstruction after total laryngectomy in China.
Main outcome will be the assessment of pronunciation effect (subjective auditory assessment).
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
- 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
- •The age is greater than 18 years; the gender is not limited
- •Performed total laryngectomy;
- •No voice prosthesis has been installed
- •Be able to take care of themselves mentally and physically, and have good hand coordination ability
- •With healthy wall sharing with trachea and esophagus
- •The patient has a desire to restore articulation function
- •Can speak Mandarin and have a certain reading ability (equivalent to primary school education)
- •The subject is fully aware of the benefits and risks of this trial and is willing to participate in and sign the informed consent form
排除标准
- •There is serious respiratory system disease or defect
- •There is a serious skin disease in the tracheostoma
- •Obvious intelligence and mental disorder
- •Tracheostoma is narrow and needs cannula implantation
- •Patients with limitation of mouth opening and other subjects with dyslalia or language disorders (such as subjects with sequelae of cerebral infarction, etc.)
- •Patients with severe respiratory disease, cardiopulmonary disease (e.g., severe arrhythmia, persons with slow ventricular rate (ventricular rate <50 beats/ min), acute phase of myocardial infarction and severe heart failure), disturbances of blood coagulation (coagulation index PT, APTT, INR> 1.5 times of the normal upper limit), septicemia and other patients not suitable
- •Patients with severe diseases of liver and renal function (liver function index, alanine aminotransferase (ALT), aspartate aminotransferase (AST)> 2 times of normal upper limit, renal function index, urine creatinine (Cr), blood urea nitrogen (BUN)> 2 times of normal upper limit);
- •Patients with local recurrence of tumor or metastatic tumor
- •If the patient has received esophageal articulation training, the time of training and using esophagus to speech should be less than 6 months
- •Women planning to have child, in lactation or pregnancy during the whole clinical study
- •Participated in other clinical trials within 1 month
- •Other candidates the investigators think not appropriate
结局指标
主要结局
Change in pronunciation effect (subjective auditory assessment)
时间窗: Baseline, 3 months, 6 months
Voice recordings judged by two independent evaluators, scored from 1-7, with lower scores meaning worse speech.
次要结局
- Change in sound intensity (minimum / maximum / comfortable);(Baseline, 3 months, 6 months)
- Change in Quality of Life by SF-36(Baseline, 3 months, 6 months)
- Change in longest articulation time (continuous /a/, count)(Baseline, 3 months, 6 months)
- Change in total time required to read a text(Baseline, 3 months, 6 months)
- Incidence of Adverse Events(Baseline, 3 months, 6 months)
- Change in Voice Handicap Index(Baseline, 3 months, 6 months)
- Evaluation of operative performance(Baseline, 3 months, 6 months)
研究者
研究点 (3)
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