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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44DK068936 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Capital Digestive Care, LLC | OTHER |
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The purpose of this study is to evaluate a handheld Colonoscopy Force Monitor(CFMâ„¢), a push-pull force and torque measuring device, that grips the shaft of the colonoscope and wirelessly transmits and records all the forces applied by the endoscopist during colonoscopy.
Colonoscopy requires a skilled endoscopist to use visual and tactile information to advance and withdraw the instrument through a series of fixed and stationary loops. To develop and maintain the skills necessary to perform colonoscopy safely and effectively requires extensive training and ongoing education. Quantification of tactile information provides the opportunity to understand the "feel" used by the endoscopist to perform colonoscopy. The identification of force application patterns has the potential to enhance training and improve performance. CFMâ„¢ is a handheld device that uses load cells to transform applied force to electric signals and to transmit wirelessly the signal to a computer for storage and visual display. The device is designed so that the endoscopist maintains a conventional hand position and uses an electronically controlled grip and release mechanism to fix the position on the instrument. Several expert endoscopists from multiple institutions will use the CFMâ„¢ to perform colonoscopy. The data will be recorded and analyzed for differences by patient characteristics(e.g. gender, age, pain sensation, surgical history) and by endoscopist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing colonoscopy | Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases. |
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| Measure | Description | Time Frame |
|---|---|---|
| CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| CFM can characterize differences in force patterns for different patients and different endoscopists | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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All adult male and female patients between the ages of 30 and 75 presenting to the Chevy Chase Endoscopy Center for screening or diagnostic colonoscopy to be performed by any of the investigators will be considered for inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Louis Y Korman, M.D. | Capital Digestive Care, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Clinic | Santa Barbara | California | 93105 | United States | ||
| Chevy Chase Endoscopy Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19922923 | Result | Korman LY, Egorov V, Tsuryupa S, Corbin B, Anderson M, Sarvazyan N, Sarvazyan A. Characterization of forces applied by endoscopists during colonoscopy by using a wireless colonoscopy force monitor. Gastrointest Endosc. 2010 Feb;71(2):327-34. doi: 10.1016/j.gie.2009.08.029. Epub 2009 Nov 17. |
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| Mayo Clinic |
| OTHER |
| Sansum Clinic | UNKNOWN |
| Georgetown University | OTHER |
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| Chevy Chase |
| Maryland |
| 20815 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |