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The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYEâ„¢ colonoscopy with that of standard colonoscopy.
This is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing G-EYEâ„¢ colonoscopy vs. the detection rate obtained by performing standard colonoscopy.
The study will enroll 350 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.
Subjects will sign an informed consent form and undergo randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-EYEâ„¢ Colonoscopy | Experimental | G-EYEâ„¢ Colonoscopy |
|
| Standard Colonoscopy | Active Comparator | Standard Colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-EYEâ„¢ Colonoscopy | Device | G-EYEâ„¢ Colonoscopy |
| |
| 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 | Approximately following 14 days (histology results) |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp and adenoma detection | The secondary outcome is a composite- each of the measured parameters will be reported as a single value for each arm. | Up to 14 days (Histology results) |
| Procedure times |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tova Rainis, Dr. | Contact | 04-8359426 | tovarainis@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tova Rainis, Dr. | Bnai Zion Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Hospital | Recruiting | Haifa | Israel |
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| ID | Term |
|---|---|
| D000236 | Adenoma |
| D011127 | Polyps |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
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| Device |
Standard Colonoscopy |
|
| At time of procedure |
| Safety (number of patients with adverse events) | 48-72 hours |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| 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 |