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| ID | Type | Description | Link |
|---|---|---|---|
| HKUCTR-2616 | Registry Identifier | HKU Clinical Trials Registry (HKUCTR) | |
| HKUCTR-2617 | Other Identifier | HKU Clinical Trials Registry (HKUCTR) |
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| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Receiving Colonoscopy | Experimental | Subjects receiving tandem colonoscopies using the NISInspire-C System followed by a Conventional Colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NISInspire-C System | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Feedback on General Usage of the NISInspire-C Disposable Colonoscope | Day 1 (Day of Procedure) |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Males Aged between 40 and 70 years; Females Aged between 55 and 70 years
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong, Queen Mary Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |