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A Clinical Validation Study of a Computerized Movement Analysis of the Colonoscope

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03587935
Recruitment Status : Completed
First Posted : July 16, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Andreas Slot Vilmann, Rigshospitalet, Denmark

Brief Summary:

Colonoscopy is the considered gold standard for diagnosing diseases in the colon. A colonoscopy is normally divided into the insertion from anus to cecum, the technical difficult part, and a retraction or diagnostic part. No objective measure exists to evaluate the performance of a colonoscopy. Based on a movement analysis of the colonoscope we wish to seek evidence for an automated and objective system able to differentiate between endoscopists with various experience in a clinical setting. The movement analysis is based on information's from the colonoscope. Electromagnetic coils are built in along the length of colonoscopes. They generate a pulsed magnetic field that is picked up a receiver coil. The data-points for each coil are inserted into an algorithm for the movement analyzing. This analysis is done as a change between the tip of the scope, and the next tracked magnetic coil. The result is a relative movement of the colonoscope in relation to the previous position.

The study is conducted a three different University Hospitals in Denmark. Twenty physicians with experience in colonoscopy are voluntary included. Patients appointed to a screening colonoscopy are included and a minimum of five consecutive colonoscopies are recorded for each physician. We predict the system to be automated and objective tool correlated with the physician's technical level of expertise in clinical colonoscopy.


Condition or disease Intervention/treatment
Colonoscopy Other: 3D-Colonoscopy Progression Score Other: 3D-Colonoscopy Retraction Score

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinical Validation Study of Two Computerized Systems Called the 3D-Colonoscopy Progression Score and 3D-Colonoscopy Retraction Score
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : January 20, 2019
Actual Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy


Intervention Details:
  • Other: 3D-Colonoscopy Progression Score
    The score is based on a movement analysis of the colonoscope from anus until max insertion(cecum). It is scaled from 0-1000. A score of zero equals an incomplete procedure and a score of 1 is a very poor score but the cecum was reached. Increasing score represents better technical performance with a maximum score of 1000.
    Other Name: 3D-CoPS
  • Other: 3D-Colonoscopy Retraction Score
    The score is based on a movement analysis of the colonoscope from cecum to the anus. It is scaled from 0-1000. A score of zero equals a very poor score, Increasing score represents better technical performance with a maximum score of 1000.
    Other Name: 3D-CoRS


Primary Outcome Measures :
  1. 3D-Colonoscopy Progression Score [ Time Frame: 8 months ]
    The score is based on a movement analysis of the colonoscope from anus until max insertion(cecum). It is scaled from 0-1000 .A score of zero equals an incomplete procedure and a score of 1 is a very poor score but the cecum was reached. Increasing score represents better technical performance with a maximum score of 1000.

  2. 3D-Colonoscopy Retraction Score [ Time Frame: 8 months ]
    The score is based on a movement analysis of the colonoscope from cecum to the anus. It is scaled from 0-1000. A score of zero equals a very poor score, Increasing score represents better technical performance with a maximum score of 1000



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Colorectal cancer screening in Denmark involves citizens in the age from 50 to 74, who is invited to volunteerly participate in screening for bowel cancer. In the course of four years (2014-2017) every person in the age group will get an invitationto the screening program. From 2018 and onwards people aged 50-74 will be invited every second year. All participants take the hemocult test and if the test is positive they will be appointed to a screening colonoscopy.
Criteria

Inclusion Criteria:

  • Physicians or nurses with a lfetime experience of more than 50 screenings colonoscopies.
  • Patients appointed to a screenings colonoscopy according to the danish screening program for colorectal cancer.

Exclusion Criteria:

  • None

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): NCT03587935


Locations
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Denmark
Copenhagen Acedemy of Medical Education and Simulation
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Technical University of Denmark
Investigators
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Study Director: Lars Konge, Prof CAMES-Rigshospitalet

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Responsible Party: Andreas Slot Vilmann, Principal Investigator Andreas Slot Vilmann, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03587935    
Other Study ID Numbers: Clinical 3D-CoPS and 3D-CoRS
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreas Slot Vilmann, Rigshospitalet, Denmark:
Colon Adenoma
Colon Polyp
Adenoma detection rate
Magnetic Endoscopy Imaging