Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Bio-Medical Engineering Limited

Status

Completed

Conditions

Colonic Polyp

Colon Adenoma

Colorectal Cancer

Treatments

Device: NISInspire-C System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03979690

NISInspire-001

HKUCTR-2616 (Registry Identifier)

HKUCTR-2617 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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