Colorectal PolypsASSEMBLENCT07005453
Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
A study testing SCALE-EYE (1) and SCALE-EYE (2) in people with Colorectal Polyps, run by Erasmus Medical Center at 3 sites in Netherlands.
Trial summary
A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population. Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- SCALE-EYE (1) and SCALE-EYE (2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 3 sitesNetherlands
- Study dates
- 23 Sep 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 55-80
- Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy
- Polyps of all forms ≤25 mm as assessed by the endoscopist
Who cannot join
- No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present
- Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) <2 per segment)
- Intraprocedural complications, not caused by the study device
- Known or suspected inflammatory bowel disease (IBD)
- Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis)
- Ileoanal pouch and anastomosis
Show all 10Show fewer
- History of radiation or chemotherapy for colorectal lesions
- Scheduled for therapeutic procedure (for example intervention to stop a lower gastro-intestinal bleeding, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD))
- Pregnancy
- No Informed consent (IC) possible
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Ramon-Michel Schreuder, Dr., +31 40 2399750, ramonmichel.schreuder@catharinaziekenhuis.nl
- Recruiting
LUMC
Leiden, South Holland, 2333 ZG
Jurjen Boonstra, Dr., +31 71 5263575, j.j.boonstra@lumc.nl
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 GD
Demi Gerritsen, MSc, +31 650033985, d.gerritsen@erasmusmc.nl
About this study
Official title: Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population.
Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.
Read the detailed description
Objective: This study aims to assess the diagnostic performance of SCALE-EYE in a screening and surveillance colonoscopy population. Also, sustainability of SCALE-EYE in terms of the reduction in colonoscopies, associated waste and carbon footprint is evaluated.
Study design: A multicenter, randomized, parallel group, endoscopist blinded study.
Study population: The unit of analysis is the colorectal polyp rather than the participants, approximately 289 colorectal polyps are planned to be included. Based on an expected detection rate of roughly 1.20 polyps per colonoscopy in the study population, approximately 241 participants aged 55-80 years old, who are referred for screening or surveillance colonoscopy at the participating study sites and have signed the informed consent form (ICF), will be included into the study. Polyps of all shapes (flat, sessile, pedunculated) that are found during colonoscopy and are smaller than 25 mm, as judged by the endoscopist using optical assessment, are considered eligible for inclusion.
Intervention: Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist and then in a randomized order measured by biopsy-forceps assisted measurement and SCALE-EYE measurement.
Primary outcome measurement: The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard.
Secondary outcome measurements:
- The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment by endoscopists for polyp size measurement.
- Sustainability (reduction of colonoscopies, the colonoscopy-associated waste and carbon footprint).
- The learning curve, this will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty.
- The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard.
- Safety, in terms of (serious) adverse events up to 30 days post-procedure.
- Conditions
- Colorectal Polyps
- Being tested
- SCALE-EYE (1), SCALE-EYE (2)
- Keywords
- virtual scale endoscopy, biopsy forceps, optical assessment, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCALE-EYE (1)Device
Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement.
SCALE-EYE (2)Device
Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE.
| Study group | Role | What they receive |
|---|---|---|
| SCALE-EYE measurement than biopsy-forceps assisted measurement | Other | When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by SCALE-EYE measurement and afterwards by biopsy-forceps assisted measurement. Receives: Device: SCALE-EYE (1) |
| Biopsy-forceps assisted measurement than SCALE-EYE measurement | Other | When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by biopsy-forceps assisted measurement and afterwards by SCALE-EYE measurement. Receives: Device: SCALE-EYE (2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCALE-EYE diagnostic performance versus biopsy-forceps
The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard.
Measured: Immediately after the screening and/or surveillance colonoscopy
Secondary outcomes (5)
SCALE-EYE diagnostic performance versus optical assessment
The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment for polyp size measurement. This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to optical assessment.
Measured: Immediately after the screening and/or surveillance colonoscopy
Sustainability
The sustainability aspect of SCALE-EYE will be assessed by exploring whether the number of colonoscopies, the colonoscopy-associated waste and carbon footprint will be reduced by correct size measurement.
Measured: After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)
Learning curve
The learning curve will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty.
Measured: Immediately after the screening and/or surveillance colonoscopy
Surveillance interval agreement
The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard (biopsy-forceps assisted measurement) will be compared.
Measured: After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)
(Serious) adverse events
Serious adverse events (SAEs) and adverse events (AEs) will be summarized by proportions.
Measured: Up to 30 days post-colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start23 Sep 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be split in two groups who will in parallel to each other undergo both SCALE-EYE measurement and biopsy-forceps assisted measurement, but there will be randomization in the order of measuring. So approximately half of the participants, in whom polyps are found, will first undergo SCALE-EYE measurement and then biopsy-forceps assisted measurement, and the other half of the participants will first undergo biopsy-forceps assisted measurement and then SCALE-EYE measurement.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Siersema, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005453
- Sponsor's protocol ID
- MEC-2024-0789
- Acronym
- ASSEMBLE
- Status last verified
- Jan 2026
- First submitted
- 1 May 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
- ClinicalTrials.gov ID
- NCT07005453
- Acronym / sponsor ID
- ASSEMBLE / MEC-2024-0789
- Conditions
- Colorectal Polyps
- Keywords
- virtual scale endoscopy, biopsy forceps, optical assessment, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 5 Jun 2025 (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.
A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population.
Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.
Detailed description
Objective: This study aims to assess the diagnostic performance of SCALE-EYE in a screening and surveillance colonoscopy population. Also, sustainability of SCALE-EYE in terms of the reduction in colonoscopies, associated waste and carbon footprint is evaluated.
Study design: A multicenter, randomized, parallel group, endoscopist blinded study.
Study population: The unit of analysis is the colorectal polyp rather than the participants, approximately 289 colorectal polyps are planned to be included. Based on an expected detection rate of roughly 1.20 polyps per colonoscopy in the study population, approximately 241 participants aged 55-80 years old, who are referred for screening or surveillance colonoscopy at the participating study sites and have signed the informed consent form (ICF), will be included into the study. Polyps of all shapes (flat, sessile, pedunculated) that are found during colonoscopy and are smaller than 25 mm, as judged by the endoscopist using optical assessment, are considered eligible for inclusion.
Intervention: Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist and then in a randomized order measured by biopsy-forceps assisted measurement and SCALE-EYE measurement.
Primary outcome measurement: The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard.
Secondary outcome measurements:
- The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment by endoscopists for polyp size measurement.
- Sustainability (reduction of colonoscopies, the colonoscopy-associated waste and carbon footprint).
- The learning curve, this will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty.
- The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard.
- Safety, in terms of (serious) adverse events up to 30 days post-procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be split in two groups who will in parallel to each other undergo both SCALE-EYE measurement and biopsy-forceps assisted measurement, but there will be randomization in the order of measuring. So approximately half of the participants, in whom polyps are found, will first undergo SCALE-EYE measurement and then biopsy-forceps assisted measurement, and the other half of the participants will first undergo biopsy-forceps assisted measurement and then SCALE-EYE measurement.
| Arm | Type | Receives |
|---|---|---|
| SCALE-EYE measurement than biopsy-forceps assisted measurement | Other | Device: SCALE-EYE (1)When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by SCALE-EYE measurement and afterwards by biopsy-forceps assisted measurement. |
| Biopsy-forceps assisted measurement than SCALE-EYE measurement | Other | Device: SCALE-EYE (2)When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by biopsy-forceps assisted measurement and afterwards by SCALE-EYE measurement. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants aged 55-80
- Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy
- Polyps of all forms ≤25 mm as assessed by the endoscopist
Key exclusion criteria (10 listed)
- No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present
- Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) <2 per segment)
- Intraprocedural complications, not caused by the study device
- Known or suspected inflammatory bowel disease (IBD)
- Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis)
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-EYE (1)Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement. | Device | SCALE-EYE measurement than biopsy-forceps assisted measurement |
| SCALE-EYE (2)Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE. | Device | Biopsy-forceps assisted measurement than SCALE-EYE measurement |
Primary outcome
SCALE-EYE diagnostic performance versus biopsy-forceps
Time frame: Immediately after the screening and/or surveillance colonoscopy
The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard.
5 secondary outcomes
SCALE-EYE diagnostic performance versus optical assessment
Time frame: Immediately after the screening and/or surveillance colonoscopy
Sustainability
Time frame: After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)
Learning curve
Time frame: Immediately after the screening and/or surveillance colonoscopy
Surveillance interval agreement
Time frame: After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)
(Serious) adverse events
Time frame: Up to 30 days post-colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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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.
Catharina Ziekenhuis
Eindhoven, Netherlands
3 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 (1) and SCALE-EYE (2) in people with Colorectal Polyps, run by Erasmus Medical Center at 3 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 10 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: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCALE-EYE diagnostic performance versus biopsy-forceps (time frame: Immediately after the screening and/or surveillance colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.