A Prospective, Pre-Market, Multicenter, Non-significant Risk Study to Validate the Performance of the Poseidon System for Fluid Management During Water-aided Colonoscopy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Human Factors as assessed using the frequency of failure
研究概览
简要总结
To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.
详细描述
The Poseidon System is a fluid management system that is investigationally indicated to provide a pathway to control waste fluid during irrigation of the colon. The Poseidon device is a manually placed and controlled device that provides support and sealing on the perimeter of an endoscope while managing fluids naturally exiting the anus, during a colonoscopy procedure. The device consists of a introducer and hand piece that allows for passage of an endoscope with valves and a retention balloon that minimize fluid passage with a single-use waste bag for collecting fluid and debris. The Poseidon™ System is not yet FDA 510(k) cleared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients will be de identified and assigned a designated number for inclusion in case report forms. Source documents will contain patient information and assigned study participant number.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or greater.
- •Patients that have an indication to undergo water-aided colonoscopy.
- •Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments.
排除标准
- •Subject unable or unwilling to provide informed consent.
- •Subjects with prolapsing hemorrhoids that require intervention or hemorrhoids that have been treated within last 3 months.
- •Prior TAMIS (Trans-anal minimally invasive surgery) or TEMS (Trans-anal micro endoscopic surgery).
- •Any condition that in the opinion of the Investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure.
- •Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
- •Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.
结局指标
主要结局
Human Factors as assessed using the frequency of failure
时间窗: 1 day
The design of the Poseidon System meets all acceptance criteria for design validation. User is able to operate device per the instructions for use. This criterion will be assessed in a pass/fail manner with an allowance of only 1 failure in the first 15 subjects and 1 failure in the second 15 subjects (if applicable).
Colonoscope Control as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
时间窗: 1 day
User shall not adversely influence typical actuation of a scope during colonoscopy procedure as assessed using a 5-point Likert scale.
Device Usability 1 as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
时间窗: 1 day
User assessment of functional acceptability of Poseidon device ratchet location as assessed using a 5-point Likert scale.
Device Usability 2 as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
时间窗: 1 day
User assessment of functional acceptability of Poseidon device intergluteal cleft fit as assessed using a 5-point Likert scale
Fluid retention as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
时间窗: 1 day
The Poseidon System shall minimize passage of fluids through and around the scope lumen when a scope is in the device, as assessed using a 5-point Likert scale.
次要结局
- Number of Adverse Events(2 weeks)
- Time measured in minutes(1 day)
- Number of Device Deficiencies(1 day)