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

NCT03587935 | Completed

• 1 other identifier: Clinical 3D-CoPS and 3D-CoRS
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Keywords

Colon Adenoma; Colon Polyp; Adenoma detection rate; Magnetic Endoscopy Imaging

Outcome Measures

Primary Outcomes (2)

• 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.

  8 months

• 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

  8 months

Interventions

3D-Colonoscopy Progression Score OTHER

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.

Also known as: 3D-CoPS

3D-Colonoscopy Retraction Score OTHER

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.

Also known as: 3D-CoRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Technical University of Denmark: collaborator

Study Sites (1)

Copenhagen Acedemy of Medical Education and Simulation

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Vilmann AS, Svendsen MBS, Lachenmeier C, Sondergaard B, Vilmann P, Park YS, Svendsen LB, Konge L. Colonoscope retraction technique and predicting adenoma detection rate: a multicenter study. Gastrointest Endosc. 2022 May;95(5):1002-1010. doi: 10.1016/j.gie.2021.12.026. Epub 2022 Jan 1.

  PMID: 34979117 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars Konge, Prof

  CAMES-Rigshospitalet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Andreas Slot Vilmann

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: July 12, 2018
• Primary Completion: January 20, 2019
• Study Completion: February 20, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)