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Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Primary Purpose

Colonic Polyp, Colon Adenoma, Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

NISInspire-C System

About this trial

This is an interventional other trial for Colonic Polyp focused on measuring Robotic Colonoscopy, Tandem Colonoscopy, NISInspire-C System, Single Use Colonoscope, Colonoscopy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

The University of Hong Kong, Queen Mary Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects Receiving Colonoscopy

Arm Description

Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy

Outcomes

Primary Outcome Measures

Safety: Incidence of Intra-Operative and Post-Operative Adverse Events

Number of Adverse Events

Feasibility: Caecal Intubation Rate (CIR)

CIR: Number of Times Caecum is Reached

Feasibility: Time-to-Caecum (TTC)

TTC: Time to Reach Caecum

Feasibility: Polyp Detection Rate (PDR)

PDR: Number of Polyps Detected

Secondary Outcome Measures

Usability

Feedback on General Usage of the NISInspire-C Disposable Colonoscope

Full Information

NCT ID

NCT03979690

First Posted

June 3, 2019

Last Updated

October 28, 2019

Sponsor

Bio-Medical Engineering (HK) Limited

Collaborators

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT03979690

Brief Title

Feasibility Study of a Novel Single Use Robotic Colonoscopy System

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 12, 2019 (Actual)

Primary Completion Date

September 16, 2019 (Actual)

Study Completion Date

September 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bio-Medical Engineering (HK) Limited

Collaborators

The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Polyp, Colon Adenoma, Colorectal Cancer

Keywords

Robotic Colonoscopy, Tandem Colonoscopy, NISInspire-C System, Single Use Colonoscope, Colonoscopy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Subjects Receiving Colonoscopy

Arm Type

Experimental

Arm Description

Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy

Intervention Type

Device

Intervention Name(s)

NISInspire-C System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety: Incidence of Intra-Operative and Post-Operative Adverse Events

Description

Number of Adverse Events

Time Frame

10 Days

Title

Feasibility: Caecal Intubation Rate (CIR)

Description

CIR: Number of Times Caecum is Reached

Time Frame

1 Hour

Title

Feasibility: Time-to-Caecum (TTC)

Description

TTC: Time to Reach Caecum

Time Frame

1 Hour

Title

Feasibility: Polyp Detection Rate (PDR)

Description

PDR: Number of Polyps Detected

Time Frame

1 Hour

Secondary Outcome Measure Information:

Title

Usability

Description

Feedback on General Usage of the NISInspire-C Disposable Colonoscope

Time Frame

Day 1 (Day of Procedure)

Other Pre-specified Outcome Measures:

Title

Intra-Procedural Pain (Exploratory Outcome)

Description

The Level of Procedural Pain Experienced by Subjects Undergoing the Colonoscopy Procedures will be Explored.

Time Frame

Day 1 (Day of Procedure)

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Males Aged between 40 and 70 years; Females Aged between 55 and 70 years

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wai Keung Leung, Professor

Organizational Affiliation

Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dominic Chi Chung Foo, Dr

Organizational Affiliation

Division of Colorectal Surgery, Department of Surgery, The University of Hong Kong, Queen Mary Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Hong Kong, Queen Mary Hospital

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of a Novel Single Use Robotic Colonoscopy System

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