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

NCT03587935 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2019-04-16

No results posted yet for this study

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.

Conditions

  • Colonoscopy

Interventions

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

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.

Sponsors & Collaborators

  • Technical University of Denmark

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Lars Konge, Prof · CAMES-Rigshospitalet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2019-01-20
Completion
2019-02-20

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587935 on ClinicalTrials.gov