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Feasibility Study of a Novel Single Use Robotic Colonoscopy System

NCT03979690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-10-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • Bio-Medical Engineering (HK) Limited

    lead INDUSTRY

Principal Investigators

  • Wai Keung Leung, Professor · Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital

  • Dominic Chi Chung Foo, Dr · Division of Colorectal Surgery, Department of Surgery, The University of Hong Kong, Queen Mary Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-12
Primary Completion
2019-09-16
Completion
2019-09-16

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03979690 on ClinicalTrials.gov