The University of Hong Kong, Queen Mary Hospital
Hong Kong
NCT Number: NCT03979690
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.
Looking for future studies?
Notify Me40 year–70 year
All sexes
Interventional
Not applicable
Hong Kong
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 10 Days
Number of Adverse Events
Time frame: 1 Hour
CIR: Number of Times Caecum is Reached
Time frame: 1 Hour
TTC: Time to Reach Caecum
Time frame: 1 Hour
PDR: Number of Polyps Detected
Time frame: Day 1 (Day of Procedure)
Feedback on General Usage of the NISInspire-C Disposable Colonoscope
Time frame: Day 1 (Day of Procedure)
The Level of Procedural Pain Experienced by Subjects Undergoing the Colonoscopy Procedures will be Explored.
Bio-Medical Engineering (HK) Limited
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04636619
Colonic Diseases, Colonic Polyp
Valladolid, Spain
View Trial DetailsNCT05242562
Colonic Diseases, Colonic Polyp
Nijmegen, Gelderland, Netherlands
View Trial DetailsNCT05854277
Colonic Diseases, Colonic Polyp
Ghent, Belgium
View Trial DetailsNCT04875793
Colonic Diseases, Colonic Polyp
Tabuk, Saudi Arabia
View Trial Details