A Pilot, Prospective, Non-randomized Study to Evaluate the Safety and Feasibility of Novel Single Use Robotic Colonoscopy System ("NISInspire-C System") in Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility: Caecal Intubation Rate (CIR)
研究概览
简要总结
This is a single centre, non-randomized, tandem colonoscopy trial of the NISInspire-C System, followed immediately by a conventional colonoscope (CC). Each trial subject will undergo colonoscopy using the NISInspire-C system, followed immediately by CC. The purpose of this study is to obtain observational data on the safety profile, feasibility and usability of the NISInspire-C System in performing diagnostic colonoscopy in human subjects. The level of procedural pain experienced by subjects will also be explored.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males aged between 40 and 70 years, inclusive, at the time of informed consent
- •Females aged between 55 and 70 years, inclusive, at the time of informed consent (Rationale: to include only women with non-childbearing potential to avoid completely pregnant trial subjects)
- •Symptomatic adults indicated for elective colonoscopy, or asymptomatic adults willing to undergo a colonoscopic screening for polyps or colorectal cancer
- •Adults without prior colonoscopy
- •Able to provide a written informed consent form approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study-specific procedures
- •Willing and able to comply with the study procedures
排除标准
- •History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, familial polyposis coli, hereditary nonpolyposis colorectal cancer syndrome, active diverticulitis or toxic megacolon
- •Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
- •Known bleeding tendency
- •Received antiplatelet or anticoagulation therapy within 3 days prior to the colonoscopy day
- •Known colonic stricture
- •Known multiple sigmoid colon diverticula
- •History of any abdominal or pelvis surgical procedures including colonic and rectal surgical resection
- •Known abdominal wall hernias
- •History of radiotherapy to the abdomen or pelvis
- •Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy day
- •Contraindication to the proposed anaesthesia
- •Received any investigational medicine or treatment within 28 days prior to Screening
- •Any condition, in the opinion of the Investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study
研究组 & 干预措施
Subjects Receiving Colonoscopy
Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy
干预措施: NISInspire-C System (Device)
结局指标
主要结局
Feasibility: Caecal Intubation Rate (CIR)
时间窗: 1 Hour
CIR: Number of Times Caecum is Reached
Feasibility: Time-to-Caecum (TTC)
时间窗: 1 Hour
TTC: Time to Reach Caecum
Feasibility: Polyp Detection Rate (PDR)
时间窗: 1 Hour
PDR: Number of Polyps Detected
Safety: Incidence of Intra-Operative and Post-Operative Adverse Events
时间窗: 10 Days
Number of Adverse Events
次要结局
- Usability(Day 1 (Day of Procedure))