A Novel Endoscopic Bite Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Successful completion of upper endoscopy procedures with the Novel Endoscopic Bite Block accessory
研究概览
简要总结
This feasibility study aims to assess the safety and effectiveness of the Novel Endoscopic Bite Block. The device will be utilized in subjects undergoing routine outpatient upper endoscopy. The investigator hypothesizes that its innovative design will reduce complications associated with bite block positioning, thereby improving procedural efficiency and patient safety.
详细描述
This study will feasibility and comfort of the novel endoscopic bite block that contains a compressible addition to the traditional endoscopic bite block offering cushioning for the teeth and the ability to resist mispositioning when a patient opens their mouth (ie, during a yawn).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of a signed and dated Informed Consent Form (ICF).
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, ≥21 years of age.
- •Deemed appropriate for scheduled upper endoscopy by endoscopists and anesthesia staff.
排除标准
- •Known allergic reactions to thermoplastic polyurethane (TPU), the component used in the manufacturing of the Flexible Endoscopic Bite Block.
- •Any medical condition that, in the opinion of the PI, makes the subject ineligible to participate in the clinical trial.
研究组 & 干预措施
Novel Bite Block
Insertion of Novel Endoscopic Bite Block in the subject's mouth following the usual manner prior to endoscopic procedure.
干预措施: Novel Bite Block (Device)
结局指标
主要结局
Successful completion of upper endoscopy procedures with the Novel Endoscopic Bite Block accessory
时间窗: Day of procedure
Proportion of endoscopic procedures that are successfully completed
Absence of dental injury during the upper endoscopy
时间窗: Day of procedure
Number and type of dental injuries occurred during the upper endoscopy
次要结局
- Endoscopist's satisfaction with lack of bite block movement(Day of procedure)