Colon Adenoma, Colonic Polyp, Colorectal Cancer
Conditions
Keywords
Robotic Colonoscopy, Tandem Colonoscopy, NISInspire-C System, Single Use Colonoscope, Colonoscopy
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.
Interventions
DEVICENISInspire-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.
Sponsors
The University of Hong Kong
Bio-Medical Engineering (HK) Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Incidence of Intra-Operative and Post-Operative Adverse Events | 10 Days | Number of Adverse Events |
| Feasibility: Caecal Intubation Rate (CIR) | 1 Hour | CIR: Number of Times Caecum is Reached |
| Feasibility: Time-to-Caecum (TTC) | 1 Hour | TTC: Time to Reach Caecum |
| Feasibility: Polyp Detection Rate (PDR) | 1 Hour | PDR: Number of Polyps Detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | Day 1 (Day of Procedure) | Feedback on General Usage of the NISInspire-C Disposable Colonoscope |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intra-Procedural Pain (Exploratory Outcome) | Day 1 (Day of Procedure) | The Level of Procedural Pain Experienced by Subjects Undergoing the Colonoscopy Procedures will be Explored. |
Countries
Hong Kong
Outcome results
None listed