NCT05499546

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

August 8, 2022

Last Update Submit

March 14, 2023

Conditions

Polyp of Colon

Keywords

Colorectal polypSizeSCALE EYEVirtual scale

Outcome Measures

Primary Outcomes (1)

  • Differences in residual variance expert endoscopists

    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.

    Through study completion, an average of 3 months

Secondary Outcomes (9)

  • Differences in residual variance expert endoscopists

    Through study completion, estimation: 3 months

  • Systematic differences expert endoscopists

    Through study completion, estimation: 3 months

  • Differences in residual variance and systematic differences trainees

    Through study completion, estimation: 3 months

  • Inter-observer variability

    Through study completion, estimation: 3 months

  • SCALE EYE measurement accuracy compared to snare measurement

    Through study completion, estimation: 3 months

  • +4 more secondary outcomes

Study Arms (1)

Intervention arm

EXPERIMENTAL

All patients within the study are included in the intervention arm: polyp detected within these patients will be measured according to the study protocol using four different methods.

Device: SCALE EYE

Interventions

SCALE EYEDEVICE

Polyp size measurement using the SCALE EYE functionality

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bergman Clinics

Amsterdam, Norod-Holland, 1105AZ, Netherlands

Location

Academic Medical Centre

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (1)

  • van Bokhorst QNE, Houwen BBSL, Hazewinkel Y, van der Vlugt M, Beaumont H, Grootjans J, van Tilburg A, Fockens P, Bossuyt PMM, Dekker E; SCALE EYE study group. Polyp size measurement during colonoscopy using a virtual scale: variability and systematic differences. Endoscopy. 2025 Feb;57(2):137-145. doi: 10.1055/a-2371-3693. Epub 2024 Jul 23.

    PMID: 39043201DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Evelien Dekker, MD, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 12, 2022

Study Start

October 11, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)