Surgical Safety Device Use During Transoral Surgery
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Surgical Field Visibility
研究概览
简要总结
The investigators are studying the use of a new medical device developed at Nationwide Children's. This technology has been licensed and produced by Zotarix LLC, a medical device company. It is designed to aid in retraction and provide protection of the lips during surgery. The investigators are not recording any of your identifiable personal health information except for the surgery date. This device, called the LabraGuard is a sterile, soft medical grade silicone, and no alternative device with these exact protective properties exists, and the investigators are trying to learn more about how it performs in different age children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 21 years of age and under
- •Having a surgical procedure done through the mouth where the lips are at risk of injury
- •Performed by attendings from either the Otolaryngology department or the Dental department.
- •Subject/Subject's guardian provides consent to be in the study
排除标准
- •Allergy to silicone
- •Unable to achieve good fit
结局指标
主要结局
Surgical Field Visibility
时间窗: baseline
Surgeons level of visibility of the oropharynx on a scale of 1 to 10
次要结局
未报告次要终点
研究者
Tendy Chiang
Assistant professor
Nationwide Children's Hospital