Polyp of ColonSCALE-EYENCT05499546
Virtual Scale Function SCALE EYE: Variability and Systematic Differences
A study testing SCALE EYE in people with Polyp of Colon, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp of Colon
- What is being tested?
- SCALE EYE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesNetherlands
- Study dates
- 11 Oct 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Screening colonoscopy after positive fecal immunochemical test (FIT) within the Dutch colorectal cancer screening program
- Signed informed consent
Who cannot join
- Diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposis syndrome
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Bergman Clinics
Amsterdam, Norod-Holland, 1105AZ
Academic Medical Centre
Amsterdam, North Holland, 1105AZ
About this study
Official title: Polyp Size Measurement During Real-time Colonoscopy Using the Virtual Scale Function SCALE EYE: Variability and Systematic Differences
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.
Read the detailed 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.
- Conditions
- Polyp of Colon
- Being tested
- SCALE EYE
- Keywords
- Colorectal polyp, Size, SCALE EYE, Virtual scale
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCALE EYEDevice
Polyp size measurement using the SCALE EYE functionality
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SCALE EYE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 months
Secondary outcomes (9)
Differences in residual variance expert endoscopists
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.
Measured: Through study completion, estimation: 3 months
Systematic differences expert endoscopists
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.
Measured: Through study completion, estimation: 3 months
Differences in residual variance and systematic differences trainees
Aforementioned parameters / outcomes (and primary study parameter) based on assessment by trainees (for other analyses assessment by experts will be used).
Measured: Through study completion, estimation: 3 months
Inter-observer variability
Inter-observer variability within techniques (residual variance).
Measured: Through study completion, estimation: 3 months
SCALE EYE measurement accuracy compared to snare measurement
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.
Measured: Through study completion, estimation: 3 months
SCALE EYE measurement accuracy compared to snare measurement for different polyp size groups
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 the 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.
Measured: Through study completion, estimation: 3 months
SCALE EYE success rate
The proportion of successful polyp size measurements by SCALE EYE during live endoscopy.
Measured: Through study completion, estimation: 3 months
SCALE EYE measurement time
Average time to manoeuver SCALE EYE during live endoscopy (i.e. time to perform measurement of one polyp).
Measured: Through study completion, estimation: 3 months
SCALE EYE satisfaction score
Satisfaction score for usage of SCALE EYE (scale from 1-10).
Measured: Through study completion, estimation: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start11 Oct 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyp of ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Evelien Dekker, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499546
- Sponsor's protocol ID
- NL81269.018.22
- Acronym
- SCALE-EYE
- Status last verified
- Mar 2023
- First submitted
- 8 Aug 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39043201
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyp Size Measurement During Real-time Colonoscopy Using the Virtual Scale Function SCALE EYE: Variability and Systematic Differences
- ClinicalTrials.gov ID
- NCT05499546
- Acronym / sponsor ID
- SCALE-EYE / NL81269.018.22
- Conditions
- Polyp of Colon
- Keywords
- Colorectal polyp, Size, SCALE EYE, Virtual scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: SCALE EYEAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Screening colonoscopy after positive fecal immunochemical test (FIT) within the Dutch colorectal cancer screening program
- Signed informed consent
Key exclusion criteria (1 listed)
- Diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposis syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCALE EYEPolyp size measurement using the SCALE EYE functionality | Device | Intervention arm |
Primary outcome
Differences in residual variance expert endoscopists
Time frame: Through study completion, an average of 3 months
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.
9 secondary outcomes
Differences in residual variance expert endoscopists
Time frame: Through study completion, estimation: 3 months
Systematic differences expert endoscopists
Time frame: Through study completion, estimation: 3 months
Differences in residual variance and systematic differences trainees
Time frame: Through study completion, estimation: 3 months
Inter-observer variability
Time frame: Through study completion, estimation: 3 months
SCALE EYE measurement accuracy compared to snare measurement
Time frame: Through study completion, estimation: 3 months
SCALE EYE measurement accuracy compared to snare measurement for different polyp size groups
Time frame: Through study completion, estimation: 3 months
SCALE EYE success rate
Time frame: Through study completion, estimation: 3 months
SCALE EYE measurement time
Time frame: Through study completion, estimation: 3 months
SCALE EYE satisfaction score
Time frame: Through study completion, estimation: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 39043201van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelien Dekker, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCALE EYE in people with Polyp of Colon, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in residual variance expert endoscopists (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.