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The study is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.
This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECV colonoscopy | Active Comparator | EndoCuff Vision® device (ECV) |
|
| G-EYE® colonoscopy | Experimental | G-EYE® colonoscope (G-EYE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDOCUFF VISION® device | Device | ENDOCUFF VISION® is a disposable cap placed on the tip of a standard colonoscope, intended to flatten colonic folds and assist in controlling the colonoscope's field of view and tip positioning |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision® | G-EYE® colonoscopy adenoma detection rate will be compared to the adenoma detection rate of EndoCuff Vision® colonoscopy. The primary performance measure is the adenoma detection rate (ADR), which is defined as the percentage of subjects with at least one adenoma found, in each of the study groups. | June 2021 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Kiesslich, Prof. | Helios Dr. Horst Schmidt Kliniken Wiesbaden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health University Hospital | Indianapolis | Indiana | 46202 | United States | ||
| NYU Langone Health |
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| ID | Term |
|---|---|
| D000236 | Adenoma |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007414 | Intestinal Neoplasms |
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Subjects will be randomized to one of two groups - ECV colonoscopy or G-EYE® colonoscopy
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| G-EYE® colonoscope | Device | The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning |
|
| New York |
| New York |
| 10016 |
| United States |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden | Wiesbaden | 65199 | Germany |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |