Actively Recruiting
Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
Led by Erasmus Medical Center · Updated on 2026-01-13
241
Participants Needed
3
Research Sites
8 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic accuracy and environmental impact of a device called SCALE-EYE during colonoscopies for screening and surveillance of colorectal polyps. This study aims to compare SCALE-EYE's polyp size measurements with the standard biopsy-forceps method, while also assessing its potential to reduce the number of colonoscopies, waste, and carbon footprint. The study includes about 241 participants aged 55 to 80 who are undergoing screening or surveillance colonoscopy and have polyps smaller than 25 mm. Participants will have a colonoscopy where detected polyps are first measured by the endoscopist using optical assessment. Then, depending on the randomized group, the polyp size will be measured by SCALE-EYE and biopsy-forceps in different sequences. The study is multicenter, randomized, and endoscopist-blinded to maintain objectivity. Both SCALE-EYE and biopsy-forceps assisted measurements are used to determine the polyp size categorization. During the study, researchers will assess SCALE-EYE’s accuracy compared to biopsy-forceps measurements, its performance against optical assessment, and its learning curve based on measurement time and difficulty. They will also evaluate the agreement in surveillance intervals recommended by the different measurement methods. Safety will be monitored by tracking adverse events up to 30 days after colonoscopy. The study will also analyze sustainability factors such as reduction in colonoscopies and related environmental impacts.
CONDITIONS
Brief Title
Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 55 to 80 years
- Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy
- Presence of colorectal polyps of all shapes smaller than or equal to 25 mm as assessed by the endoscopist
You will not qualify if you...
- No detected colorectal polyps or only diminutive hyperplastic rectal polyps (≤5 mm)
- Inadequate bowel preparation (Boston Bowel Preparation Score less than 2 per segment)
- Intraprocedural complications not caused by the study device
- Known or suspected inflammatory bowel disease (IBD)
- Polyposis syndromes such as serrated polyposis or familial adenomatous polyposis
- Presence of ileoanal pouch and anastomosis
- History of radiation or chemotherapy for colorectal lesions
- Scheduled for therapeutic procedures like intervention for lower gastrointestinal bleeding, endoscopic mucosal resection (EMR), or endoscopic submucosal dissection (ESD)
- Pregnancy
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a colonoscopy during which any detected colorectal polyps smaller than 25 mm are measured using optical assessment, SCALE-EYE, and biopsy-forceps assisted measurement in a randomized order.
1 procedure visit (in-person)
Duration - Up to 30 days post-colonoscopy
Participants are monitored for safety and sustainability outcomes including adverse events, surveillance interval agreement, and environmental impact up to 30 days after the colonoscopy.
1 follow-up visit or contact
Trial Site Locations
Total: 3 locations
1
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623 EJ
Actively Recruiting
2
LUMC
Leiden, South Holland, Netherlands, 2333 ZG
Actively Recruiting
3
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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