试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 3
- 主要终点
- Complications (bleeding, perforation, damage to non target tissue)
研究概览
简要总结
This study is intended to collect data regarding treatment with a new flexible fiber used to transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study will include a single treatment that is performed transorally (through the mouth) for oral or laryngeal indications in the field of Ear, Nose and Throate (ENT).
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
- •General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure.
- •Able and willing to comply with all visit, treatment and evaluation schedule and requirements
- •Able to understand and provide written Informed Consent
- •Disease which requires tissue ablation for treatment
排除标准
- •Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion);
- •Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process
- •Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
- •Any condition which, in the Physician's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research
结局指标
主要结局
Complications (bleeding, perforation, damage to non target tissue)
时间窗: During intervention and up to 6 weeks following the procedure
Number of subjects with Adverse Events as a Measure of Safety
Ability to complete procedure with the study device
时间窗: Immediate - during intervention
The number of interventions that were completed using the AcuPulse WG and FiberLase CO2 Fiber for the intended indication, without the need to revert to other means
次要结局
未报告次要终点