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61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
This will be a prospective single-center non-blinded clinical investigation. Each subject will undergo a colonoscopy to the cecum with the Aer-O-Scope Colonoscope System. All pathologies found will be removed. No control group is necessary as the main objective is to reach the cecum. Either the cecum is intubated or it is not. This is true for all colonoscopy procedures.
Up to the first ten (10) cases for each physician will be system operation training cases.
The primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Cohort | Experimental | 61 subjects will undergo colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aer-O-Scope Colonoscopy | Device | resection or biopsy of colonic abnormalities for histopathalogical evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aer-O-Scope Validation of Cecal Intubation | The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Gluck, MD | Tel Aviv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sourasky Medical Center | Tel Aviv | Israel |
No individual patient data will be shared
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 10, 2022 | |
| Reset | Jul 11, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 10, 2022 | Jul 11, 2023 |
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A single group of subjects will undergo diagnostic, screening or surveillance colonoscopy.
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| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |