Using SCALE-EYE to measure colorectal polyp size accurately and reduce procedure waste

Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy

This trial tests whether SCALE-EYE can accurately measure polyp size during screening or surveillance colonoscopy in people aged 55–80 and whether its use can cut down on follow-up procedures and waste.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 241 (estimated)
• Ages: 55 Years to 80 Years
• Sex: All
• Sponsor: Erasmus Medical Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Eindhoven, North Brabant and 2 other locations)
• Trial ID: NCT07005453 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, parallel-group, endoscopist-blinded study comparing SCALE-EYE measurements to biopsy-forceps assisted measurement and standard optical assessment during real-time screening and surveillance colonoscopies. The unit of analysis is the colorectal polyp, with about 289 polyps expected from roughly 241 participants aged 55–80 who are referred for FIT screening or surveillance colonoscopy. Polyps under 25 mm of any shape detected during colonoscopy will be measured first by the endoscopist's optical estimate and then, in randomized order, by biopsy-forceps assisted measurement and SCALE-EYE. The study also quantifies sustainability outcomes including reductions in colonoscopies, associated waste, and carbon footprint if SCALE-EYE changes management.

Who should consider this trial

Good fit: Ideal participants are adults aged 55–80 scheduled for FIT screening or surveillance colonoscopy who consent and have one or more colorectal polyps ≤25 mm detected during the procedure.

Not a fit: Patients who have no detected polyps, only diminutive (≤5 mm) hyperplastic rectal polyps, inadequate bowel preparation, known IBD, polyposis syndromes, or other listed exclusions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SCALE-EYE could improve polyp sizing accuracy, potentially reducing unnecessary polypectomies and follow-up colonoscopies while lowering medical waste and carbon emissions.

How similar studies have performed: Prior pilot and single-center work on optical and virtual measuring tools has shown promising accuracy, but a multicenter randomized, blinded comparison of SCALE-EYE is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Eindhoven, North Brabant and 2 other locations

• Catharina Ziekenhuis — Eindhoven, North Brabant, Netherlands (RECRUITING)
• LUMC — Leiden, South Holland, Netherlands (RECRUITING)
• Erasmus MC — Rotterdam, South Holland, Netherlands (RECRUITING)

Conditions: Colorectal Polyps, virtual scale endoscopy, biopsy forceps, optical assessment, colorectal cancer