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Trial record 45 of 318 for:    colon cancer | ( Map: Canada )

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

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ClinicalTrials.gov Identifier: NCT01969292
Recruitment Status : Terminated (Stage 1 Complete; Stage 2 and 3 not pursued)
First Posted : October 25, 2013
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Christopher Andrews, University of Calgary

Brief 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Other: Colometer Other: Sham Software Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
Study Start Date : September 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Colometer
Colometer software will be engaged during the colonoscopy to provide real time feedback to the endoscopist.
Other: Colometer
Real time software based image analysis tool.

Sham Comparator: Sham Software
An identical set-up to the experimental arm but with a green band showing across the top for the duration of the colonoscopy.
Other: Sham Software
Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.

No Intervention: Control
Recordings of colonoscopies made without Colometer or sham feedback during the course of the colonoscopy will be evaluated retrospectively using the Colometer software.



Primary Outcome Measures :
  1. %Clear [ Time Frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes ]
    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.


Secondary Outcome Measures :
  1. Average withdrawal velocity [ Time Frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes. ]
  2. Ottawa Stool Score [ Time Frame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969292


Locations
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Canada, Alberta
Forzani&MacPhail Colon Cancer Screening Centre
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
Christopher Andrews
Investigators
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Principal Investigator: Christopher N Andrews, MD MSc University of Calgary

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Responsible Party: Christopher Andrews, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT01969292     History of Changes
Other Study ID Numbers: Col001
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: January 2016
Keywords provided by Christopher Andrews, University of Calgary:
colonoscopy
quality assurance
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases