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To evaluate the safety of using the NaviAidâ„¢ G-Eye system during Colonoscopy
Colonoscopy is the gold-standard method for CRC screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. It is well known that lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due to incomplete colonoscopy) and endoscope slippage. The NaviAidâ„¢ G-Eye system presents a unique concept that overcomes all 5 items listed above, providing an overall solution to the two endoscopy key challenges of limited detection/treatment yield and limited operation range.
The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is permanently integrated, at its bending section. The NaviAidâ„¢ G-Eye may be used for performing controlled withdrawal and endoscope stabilization.
A major attribute of the NaviAidâ„¢ G-Eye system controlled withdrawal technique of the endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen during endoscope withdrawal.
This is a single-center, non randomized open-label study intended to evaluate the serious adverse events prevalence when using the NaviAidâ„¢ G-Eye system during colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaviAidâ„¢ G-Eye procedure | Experimental | NaviAidâ„¢ G-Eye procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaviAidâ„¢ G-Eye procedure | Device | NaviAidâ„¢ G-Eye procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | To evaluate the safety of using the NaviAidâ„¢ G-Eye system during Colonoscopy | Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian M Gralnek, Prof. | Elisha Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elisha Hospital | Haifa | 34636 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25225962 | Derived | Gralnek IM, Suissa A, Domanov S. Safety and efficacy of a novel balloon colonoscope: a prospective cohort study. Endoscopy. 2014 Oct;46(10):883-7. doi: 10.1055/s-0034-1377968. Epub 2014 Sep 16. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011127 | Polyps |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |