Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979690
• Other study ID #: NISInspire-001
• Secondary ID: HKUCTR-2616HKUCT
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: September 16, 2019

Study information

• Verified date: October 2019
• Source: Bio-Medical Engineering (HK) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colonic Polyp
• Colonic Polyps
• Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong, Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Bio-Medical Engineering (HK) Limited	The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-Procedural Pain (Exploratory Outcome)	The Level of Procedural Pain Experienced by Subjects Undergoing the Colonoscopy Procedures will be Explored.	Day 1 (Day of Procedure)
Primary	Safety: Incidence of Intra-Operative and Post-Operative Adverse Events	Number of Adverse Events	10 Days
Primary	Feasibility: Caecal Intubation Rate (CIR)	CIR: Number of Times Caecum is Reached	1 Hour
Primary	Feasibility: Time-to-Caecum (TTC)	TTC: Time to Reach Caecum	1 Hour
Primary	Feasibility: Polyp Detection Rate (PDR)	PDR: Number of Polyps Detected	1 Hour
Secondary	Usability	Feedback on General Usage of the NISInspire-C Disposable Colonoscope	Day 1 (Day of Procedure)