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The goal of this observation study is to learn about the feasibility of a new colonoscope which provides the physician an extra-wide field of view during a screening colonoscopy. The main question this study aims to answer is can this new type of colonoscope locate polyps during clinical use in patients.
Patients will undergo a routine colonoscopy for colorectal cancer or polyp surveillance and have one follow-up phone call up to 2 weeks of the colonoscopy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EFOV Colonoscope | Device | Routine colonoscopy using the EFOV lens in the colonoscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Cecal Intubation Rate | The proportion of procedures in which the cecum was reached. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Total procedure time and separated into cecal insertion time, time to reach ileum and withdrawal time. | Day 1 |
| Ileum Intubation Rate | Success rate of reaching the Ileum. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults scheduled for screening colonoscopies, evaluation of a positive stool test or polyp surveillance colonoscopy.
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| Name | Affiliation | Role |
|---|---|---|
| Horst Neuhaus, MD, PhD | RKM 740 Interdisciplinary Specialist Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RKM 740 Interdisciplinary Care Clinic - Gastroenterology | Düsseldorf | Germany |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Day 1 |
| Therapeutic Intervention Success Rate | The ability to collect a biopsy or remove a polyp. | Day 1 |
| Mean number of polyps per coloscopy and its detection rate | Count of number of polyps seen during colonoscopy | Day 1 |
| Mean number of adenomas and its detection rate | Count of number of adenomas/sessile serrate lesions defined by pathology | Day 14 |
| Mean number of sessile serrate lesions and its detection rate | Count of number of adenomas/sessile serrate lesions defined by pathology | Day 14 |
| Patient Satisfaction Survey | During a follow-up phone call, the patient will be asked a yes or no question to rate their satisfaction of the procedure. | Day 14 |