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Clinical Trial NCT07005453 (ASSEMBLE) for Colorectal Polyps is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size (ASSEMBLE) 241 Randomized
Clinical Trial NCT07005453 (ASSEMBLE) is an interventional study for Colorectal Polyps that is recruiting. It started on 23 September 2025 with plans to enroll 241 participants. Led by Erasmus Medical Center, it is expected to complete by 1 April 2026. The latest data from ClinicalTrials.gov was last updated on 13 January 2026.
Brief 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.
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 t...
Show MoreOfficial Title
Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
Conditions
Colorectal PolypsOther Study IDs
- ASSEMBLE
- MEC-2024-0789
NCT ID Number
Start Date (Actual)
2025-09-23
Last Update Posted
2026-01-13
Completion Date (Estimated)
2026-04-01
Enrollment (Estimated)
241
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
virtual scale endoscopy
biopsy forceps
optical assessment
colorectal cancer
biopsy forceps
optical assessment
colorectal cancer
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherSCALE-EYE measurement than biopsy-forceps assisted measurement 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. | 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. |
OtherBiopsy-forceps assisted measurement than SCALE-EYE measurement 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. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | Immediately after the screening and/or surveillance colonoscopy |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 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. | 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. | Up to 30 days post-colonoscopy |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
55 Years
Eligible Sexes
All
- 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
- 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
- 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
Erasmus Medical CenterStudy Responsible Party
Peter Siersema, Principal Investigator, Prof. Dr. P.D. Siersema, Erasmus Medical Center
No contact data.
3 Study Locations in 1 Countries
North Brabant
Catharina Ziekenhuis, Eindhoven, North Brabant, 5623 EJ, Netherlands
Ramon-Michel Schreuder, Dr., Contact, +31 40 2399750, [email protected]
Recruiting
South Holland
LUMC, Leiden, South Holland, 2333 ZG, Netherlands
Jurjen Boonstra, Dr., Contact, +31 71 5263575, [email protected]
Recruiting
Erasmus MC, Rotterdam, South Holland, 3015 GD, Netherlands
Demi Gerritsen, MSc, Contact, +31 650033985, [email protected]
Recruiting