Case Series With Saneso 3600 Colonoscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Intubation of terminal ileum and cecum
研究概览
简要总结
Saneso colonoscope is a novel FDA cleared colonoscope that provides a 360 degree integrated view of the colon. Saneso colonoscope has five cameras and multiple LED lights at the distal head. The objective of the present study is to evaluate clinical success of the Saneso colonoscope in intubation of the terminal ileum and to obtain user feedback with regards to usability characteristics compared to predicate devices.
详细描述
This study is a prospective, multi-center case series of per standard of care colonoscopy procedures using a nonsignificant risk Saneso 360 degree colonoscope. 40 cases were included at 3 clinical sites. Patients who meet all eligibility criteria were included and had a clinically indicated colonoscopy procedure performed using the study device. Immediately thereafter, patients had a colonoscopy procedure using standard colonoscope (Olympus CF 180) by a second endoscopist. Enrolled subjects were followed for 7 days after their procedure. If the procedure was not successful with the study device, the endoscopist completed the procedure with a traditional colonoscope used at each facility. This study was approved by the institutional review board of respective sites. The clinical trial was conducted in accordance with the standards of Good Clinical Practice (GCP) and in accordance with the principles of the Declaration of Helsinki.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •45 -74 years of age Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
- •Scheduled for a clinically indicated routine colonoscopy procedure ASA class 1-3.
排除标准
- •Altered colon anatomy Pregnant women, children under 18 years of age and adults over 75 years of age. Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.
- •Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor ASA class 4-5.
结局指标
主要结局
Intubation of terminal ileum and cecum
时间窗: 4 months.
Intubation of the terminal ileum and cecum
次要结局
- User feedback for operating characteristics of the device(4 months.)