NCT04544800终止不适用
Development of Upper Aerodigestive Tract Splint
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Physician Splint Satisfaction Questionnaire
研究概览
简要总结
The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.
详细描述
This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Require a procedure involving the upper aerodigestive tract (UADT)
排除标准
- •Prior surgery to tongue or mouth that precludes the use of the splint
- •Trismus with mouth opening that does not allow for use of the splint
- •TMJ dysfunction that precludes the use of the splint
- •Allergy to local anesthetic
研究组 & 干预措施
Use of Splint for UADT Visualization
Experimental
Use of device to view UADT
干预措施: Use of Splint for UADT Visualization (Device)
结局指标
主要结局
Physician Splint Satisfaction Questionnaire
时间窗: Immediately after the intervention/procedure/surgery
A 14-item questionnaire to evaluate the surgeon satisfaction with the splint.
Patient Splint Satisfaction Questionnaire
时间窗: Immediately after the intervention/procedure/surgery
Self-administered, 6-item questionnaire to evaluate splint satisfaction.
次要结局
未报告次要终点
研究者
研究点 (2)
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