Virtual Scale Function SCALE EYE: Variability and Systematic Differences

Last updated: March 14, 2023
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Completed

Phase

N/A

Condition

Polyps

Colon Polyps

Treatment

N/A

Clinical Study ID

NCT05499546
NL81269.018.22
  • Ages > 18
  • All Genders

Study Summary

Size of colorectal polyps is important to decide on appropriate surveillance intervals and treatment modality, as well as carrying out optical diagnosis strategies. However, polyp size measurement is often prone to inter-observer variability. An easy and accurate tool to assist in polyp size measurement is required. Recently, a virtual scale function for size measurement during endoscopy (SCALE EYE), operating in real-time without the use of any additional devices, has been developed. The aim of this study is to assess whether use of the SCALE EYE for polyp size measurement can reduce inter-observer variability.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years
  • Screening colonoscopy after positive fecal immunochemical test (FIT) within the Dutchcolorectal cancer screening program
  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposissyndrome

Study Design

Total Participants: 52
Study Start date:
October 11, 2022
Estimated Completion Date:
March 01, 2023

Study Description

This study is designed as a single center prospective study. Polyp size measurements using SCALE EYE will be compared with several other polyp size measurement techniques: size measurements by endoscopists without a reference ('carpenters eye') , size measurements by endoscopists with an opened snare (of known size) as reference and size measurements by the pathologist during histopathological analysis.

During screening colonoscopies, detected polyps (maximum of four per colonoscopy) will be measured using all three different colonoscopy measurement techniques. This will be done by experienced endoscopists (endoscopist accredited for colonoscopies within the national colorectal cancer screening program). Since endoscopists measure polyps in multiple ways, consecutive measurements of the same polyp will be biased. For this reason, all polyp size measurements will be recorded on video. The video recordings of the different measurements of all polyps will be presented to eight expert endoscopists and four to eight trainees (depending on availability) in a randomized order. The size estimations based on these video recordings will be used for further analysis. Histopathological analysis and size measurements of the resected polyps will be performed by pathologists with expertise in gastrointestinal pathology. Variability and systematic differences in polyp size measurement between different measurements methods will be assessed.

Connect with a study center

  • Academic Medical Centre

    Amsterdam, Noord-Holland 1105AZ
    Netherlands

    Site Not Available

  • Bergman Clinics

    Amsterdam, Norod-Holland 1105AZ
    Netherlands

    Site Not Available

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