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The purpose of this study is to compare the adenoma detection rate of G-EYEâ„¢ high definition colonoscopy with that of standard high definition colonoscopy.
Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy |
|
| Group B | Active Comparator | Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Colonoscopy | Procedure | Standard Colonoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| G-EYEâ„¢ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same. | estimated 14 days (following histology results) |
| Measure | Description | Time Frame |
|---|---|---|
| polyp and adenoma detection, procedure times and safety | 24-72 hours post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Kiesslich, Prof. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Marienkrankenhaus Frankfurt | Frankfurt | 60318 | Germany |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| G-EYE(TM) Colonoscopy |
| Procedure |
G-EYE(TM) Colonoscopy |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |