Feasibility Study of a Novel Single Use Robotic Colonoscopy System

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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