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Megachannel is a newly developed colonic access system allowing rapid and multiple passes of the colonoscope to the right colon.
The investigators want to conduct a multinational study to evaluate the safety and clinical feasibility of placing a 100 cm Megachannel prototype in the right colon.
Patients scheduled for colonoscopy with suspected right colonic polypoid lesions will be included. The prototype will loaded onto a 160 cm lower GI endoscope and introduced via colonoscopic guidance. Time to cecum, total investigation time, clinical feasibility and complications will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Megachannel Application | Experimental | Colonoscopy with loaded Megachannel is performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy with Megachannelâ„¢ device loaded | Device | Before colonoscopy, megachannel is loaded on the endoscope, during colonoscopy megachannel will be inserted into the patient via the endoscope placed in the colon |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and clinical feasibility of performing colonoscopy with megachannel | during every single colonoscopy in the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnulf Ferlitsch, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18455170 | Background | Silberhumer GR, Birsan T, Noda W, Unger E, Mayr W, Lang S, Prager G, Gasche C. Design and instrumentation of new devices for performing appendectomy at colonoscopy (with video). Gastrointest Endosc. 2008 Jul;68(1):139-45. doi: 10.1016/j.gie.2008.02.024. Epub 2008 May 2. | |
| 20438892 | Derived | Ferlitsch A, Silberhumer GR, Noda W, Birsan T, Desai D, Kumar A, Rao GV, Khakar A, Gomez NA, Gasche C. A novel endoscopic device for repeated right-side colonic access during colonoscopy (with video). Gastrointest Endosc. 2010 May;71(6):1052-5. doi: 10.1016/j.gie.2009.12.059. |
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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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|
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |