Case Series With Saneso 3600 Gastroscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 12
- 主要终点
- Successful EGD
研究概览
简要总结
To confirm the procedural performance of the Saneso 360° gastroscope in Esophago-gastro-duodenoscopy (EGD) procedures.
详细描述
This study is a prospective, multicenter case series per standard of care EGD procedures using a nonsignificant risk Saneso 360° gastroscope. 20 cases will be included at up to five (5) clinical sites. Patients who meet all eligibility criteria will be included and will have a clinically indicated EGD procedure performed using the study device. Immediately thereafter, patients will have an EGD procedure using a standard Gastroscope (Olympus GIF180) by a second endoscopist. Enrolled subjects will be followed for 7 days after their procedure. If the procedure is not successful with the study device, the endoscopist will complete the procedure with a traditional gastroscope used at each facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 -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 EGD procedure
- •ASA class 1-3.
排除标准
- •Altered esophageal, gastric, or duodenal 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
Successful EGD
时间窗: Within 24 hours on study day
Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken.
次要结局
- Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG)(Within 7 days of completion of the study)
- Evaluation of adverse events (AEs) related to the device.(Within 7 days of completion of the study)
- Endoscopist qualitative rating of the Saneso 360° gastroscope(Within 24 hours on study day)
- Evaluation of any potential mucosal injury(Immediately after the use of the device)