Not provided
Not provided
Not provided
Not provided
Not provided
Stage 1 Complete; Stage 2 and 3 not pursued
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colometer | Experimental | Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist. |
|
| Sham Software | Sham Comparator | An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy. |
|
| Control | No Intervention | Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colometer | Other | Real time software based image analysis tool. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| %Clear | This is defined as the Percentage of the total withdrawal time where the withdrawal velocity is below a set speed limit and the view is clear (ie, not blurry) as measured by the software. Visualization of the colon lumen is ideal with a slow, non-blurry view in order to detect polyps. | Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Average withdrawal velocity | Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes. | |
| Ottawa Stool Score | Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher N Andrews, MD MSc | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forzani&MacPhail Colon Cancer Screening Centre | Calgary | Alberta | T2N 4Z6 | Canada |
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Software |
| Other |
Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy. |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |