NCT03979690

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bio-Medical Engineering (HK) Limited · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Colonic Polyp
• Colon Adenoma
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	NISInspire-C System	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.

Timeline

• Start date: 2019-06-12
• Primary completion: 2019-09-16
• Completion: 2019-09-16
• First posted: 2019-06-07
• Last updated: 2019-10-30

Locations

1 site across 1 country: Hong Kong