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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A03292-53 | Other Identifier | ANSM |
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Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Standard colonoscopy then colonoscopy with G-EYE | Experimental | Arm A: Standard colonoscopy then colonoscopy with G-EYE |
|
| Arm B: G-EYE colonoscopy then standard colonoscopy | Experimental | Arm B: G-EYE colonoscopy then standard colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-EYE first and standard colonoscope | Device | Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) | Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections | Colonoscopy time |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) | Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections | Colonoscopy time |
| Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe RATONE, MD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Marseille | Bouches Du Rhone | 13009 | France |
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| ID | Term |
|---|---|
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Prospective, single-phase, two-stage, randomized phase II study
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| standard colonoscope first and G-EYE | Device | Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device) |
|
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female |
| Colonoscopy time |
| Rate of complications | Global and for each arm | Colonoscopy time and 1 month after |
| Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup | Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup | Colonoscopy time |
| Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup | Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup | Colonoscopy time |
| G-EYE assistance for endoscope stabilization | Yes or no | Colonoscopy time |