Feasibility Study of a Novel Single Use Robotic Colonoscopy System

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colonic Polyp; Colon Adenoma
• Intervention / Treatment: Device: NISInspire-C System

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong, Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Subjects Receiving Colonoscopy; Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Feedback on General Usage of the NISInspire-C Disposable Colonoscope	Day 1 (Day of Procedure)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Bio-Medical Engineering (HK) Limited
• Collaborators: The University of Hong Kong
• Investigators: Principal Investigator: Wai Keung Leung, Professor, Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital; Principal Investigator: Dominic Chi Chung Foo, Dr, Division of Colorectal Surgery, Department of Surgery, The University of Hong Kong, Queen Mary Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2019
• Primary Completion (ACTUAL): September 16, 2019
• Study Completion (ACTUAL): September 16, 2019

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (ACTUAL): June 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Colonoscopy; Robotic Colonoscopy; Tandem Colonoscopy; NISInspire-C System; Single Use Colonoscope
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: NISInspire-001; HKUCTR-2616 (REGISTRY: HKU Clinical Trials Registry (HKUCTR)); HKUCTR-2617 (OTHER: HKU Clinical Trials Registry (HKUCTR))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No