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The aim of the first-in-human clinical trial is to evaluate the feasibility of performing colonoscopic polypectomy with a novel colonic intraluminal endoscopic support structure (CIESS) in-situ
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy and polypectomy with Colonic Intraluminal Endoscopic Support Structure in-situ | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonic Intraluminal Endoscopic Support Structure | Device | During colonoscopy, if a left-sided colonic polyps is identified, the colonic intraluminal endoscopic support structure (CIESS) will be deployed. Routine polypectomy will be performed. CIESS will be retrieved after polypectomy is completed. Colonoscopy will be completed as per normal routine.Other Name: |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to deploying CIESS in a single attempt | Primary outcome measure is whether the CIESS can be deployed successfully in a single attempt - this is a measure of the feasibility of deploying the CIESS during colonoscopy. This outcome will be recorded as "successfully deployed in a single attempt or unsuccessfully deployed in a single attempt" | From enrollment to end of treatment at 4 weeks |
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Inclusion Criteria:
Positive fecal occult blood test
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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