Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Not Applicable

Completed

• Conditions: Colon Adenoma; Colonic Polyp; Colorectal Cancer

• Registration Number: NCT03979690
• Lead Sponsor: Bio-Medical Engineering (HK) Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-06-12
• Primary Completion: 2019-09-16
• Study Completion: 2019-09-16
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility: Caecal Intubation Rate (CIR)	1 Hour	CIR: Number of Times Caecum is Reached
Feasibility: Time-to-Caecum (TTC)	1 Hour	TTC: Time to Reach Caecum
Feasibility: Polyp Detection Rate (PDR)	1 Hour	PDR: Number of Polyps Detected
Safety: Incidence of Intra-Operative and Post-Operative Adverse Events	10 Days	Number of Adverse Events

Secondary Outcome Measures

Name	Time	Method
Usability	Day 1 (Day of Procedure)	Feedback on General Usage of the NISInspire-C Disposable Colonoscope

Trial Locations

Locations (1)

The University of Hong Kong, Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong