Polyp size measurement during real-time colonoscopy using the virtual scale function SCALE EYE: variability and systematic differences

Polyp size measurement during real-time colonoscopy using the virtual scale function SCALE EYE: variability and systematic differences - SCALE EYE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51622

Enrollment

Registered

2022-07-21

Start date

2022-10-10

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bowel polyps colorectal polyps

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: - Age >18 years - Screening colonoscopy after positive fecal immunochemical test (FIT) within the Dutch colorectal cancer screening program - Signed informed consent

Exclusion criteria

Exclusion criteria: Patients: - Patients with diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposis syndrome - Patients who are unwilling or unable to give informed consent Colorectale poliepen: - Polyps greater than 20 mm (based on initial visual size measurement by the executing endoscopist without endoscopic tool as visual reference) - Polyps removed in a way other than cold snare resection

Design outcomes

Primary

Measure	Time frame
The difference in residual variance (variability) between (1) polyp size measurement with SCALE EYE and (2) polyp size measurement using an opened snare (of known size) as reference.	—

Secondary

Measure	Time frame
- The difference in residual variance (variability) between polyp size measurement with (1) the SCALE EYE functionality, (2) polyp size measurement without reference and (3) polyp size measurement during histopathological analysis. - The systematic difference in polyp size measurements between (1) the SCALE EYE functionality and the other measurement techniques: (2) polyp size measurement without reference, (3) polyp size measurement with an opened snare as a visual reference and (4) polyp size measurement during histopathological analysis. - Aformentioned parameters / outcomes (and primary study paramater) based on assessment by fellow endoscopists (for other analyses assessment by experts will be used) - Inter-observer variability within techniques (residual variance) - The accuracy of the SCALE EYE functionality for predicting the size of polyps. Accuracy is defined as the percentage of correctly predicted polyp sizes with the SCALE EYE functionality when polyp size measurement with an opened snare is considered as reference standard. Polyp size will be assigned as correctly predicted if the polyp size measurement with SCALE EYE lies within a 25% margin of error. The mean of the polyp size measurements by all experts endoscopists will be used for the comparison. - The accuracy of the SCALE EYE functionality for predicting polyp size for different polyp size categories (1-5 mm vs. 6-9 mm vs. >10 mm). Accuracy is defined as the percentage of correctly predicted polyp sizes with the SCALE EYE functionality when polyp size measurement with an opened snare is considered as reference standard. Polyp size will be assigned as correctly predicted if the polyp size measurement with SCALE EYE lies within a 25% margin of error. The mean of the polyp size measurements by all expert endoscopists will be used to assign the polyp size category. - The proportion of successful polyp size measurements by SCALE EYE during live endoscopy - Average time t	—

Measure

Time frame

- The difference in residual variance (variability) between polyp size measurement with (1) the SCALE EYE functionality, (2) polyp size measurement without reference and (3) polyp size measurement during histopathological analysis. - The systematic difference in polyp size measurements between (1) the SCALE EYE functionality and the other measurement techniques: (2) polyp size measurement without reference, (3) polyp size measurement with an opened snare as a visual reference and (4) polyp size measurement during histopathological analysis. - Aformentioned parameters / outcomes (and primary study paramater) based on assessment by fellow endoscopists (for other analyses assessment by experts will be used) - Inter-observer variability within techniques (residual variance) - The accuracy of the SCALE EYE functionality for predicting the size of polyps. Accuracy is defined as the percentage of correctly predicted polyp sizes with the SCALE EYE functionality when polyp size measurement with an opened snare is considered as reference standard. Polyp size will be assigned as correctly predicted if the polyp size measurement with SCALE EYE lies within a 25% margin of error. The mean of the polyp size measurements by all experts endoscopists will be used for the comparison. - The accuracy of the SCALE EYE functionality for predicting polyp size for different polyp size categories (1-5 mm vs. 6-9 mm vs. >10 mm). Accuracy is defined as the percentage of correctly predicted polyp sizes with the SCALE EYE functionality when polyp size measurement with an opened snare is considered as reference standard. Polyp size will be assigned as correctly predicted if the polyp size measurement with SCALE EYE lies within a 25% margin of error. The mean of the polyp size measurements by all expert endoscopists will be used to assign the polyp size category. - The proportion of successful polyp size measurements by SCALE EYE during live endoscopy - Average time t

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Countries

Netherlands

Outcome results