Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2019-09-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Colonic Polyp Colon Adenoma Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Subjects Receiving Colonoscopy

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

Group Type EXPERIMENTAL

NISInspire-C System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes