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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
The NISInspire-C System is a disposable robotic colonoscopy system that consists of a flexible slender insertion tube designed to ensure non-invasive, reliable and safe colorectal screening. It comprises of two components: NISInspire-C Console, and the NISInspire-C Disposable Colonoscope.
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Safety: Incidence of Intra-Operative and Post-Operative Adverse Events
Number of Adverse Events
Time frame: 10 Days
Feasibility: Caecal Intubation Rate (CIR)
CIR: Number of Times Caecum is Reached
Time frame: 1 Hour
Feasibility: Time-to-Caecum (TTC)
TTC: Time to Reach Caecum
Time frame: 1 Hour
Feasibility: Polyp Detection Rate (PDR)
PDR: Number of Polyps Detected
Time frame: 1 Hour
Usability
Feedback on General Usage of the NISInspire-C Disposable Colonoscope
Time frame: Day 1 (Day of Procedure)
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