Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

Colon Cancer Clinical Trial

Official title:

Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01969292
• Other study ID #: Col001
• Status: Terminated
• Phase: N/A
• First received: September 26, 2013
• Last updated: August 17, 2016
• Start date: September 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients: patients categorized as normal risk who have been referred for screening colonoscopy at the Forzani & MacPhail Colon Cancer Screening Centre in Calgary, Alberta

• Endoscopists: Gastroenterologists with practices at the Forzani & MacPhail Colon Cancer Screening Centre, Calgary, Alberta

Exclusion Criteria:

• Patients: patients who are not categorized as normal risk

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Other:
• Colometer
Real time software based image analysis tool.
• Sham Software
Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.

Locations

Country	Name	City	State
Canada	Forzani&MacPhail Colon Cancer Screening Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Christopher Andrews

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%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	No
Secondary	Average withdrawal velocity		Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.	No
Secondary	Ottawa Stool Score		Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.	No