Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Study Overview
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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.

Official Title
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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

Conditions
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Colonic Polyp, Colon Adenoma, Colorectal Cancer

Intervention / Treatment
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* Device: NISInspire-C System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects Receiving Colonoscopy<br>Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy | Device: NISInspire-C System<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Colonoscopy, Tandem Colonoscopy, NISInspire-C System, Single Use Colonoscope, Colonoscopy