Clinical trial · Interventional
Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
NCT07005453CI-TRIAL-00100749ASSEMBLErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Polyps | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCALE-EYE (1) | Device | — | UNRESOLVED |
| SCALE-EYE (2) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- SCALE-EYE measurement than biopsy-forceps assisted measurement
- description
- 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.
- interventionNames
- Device: SCALE-EYE (1)
- type
- OTHER
- label
- Biopsy-forceps assisted measurement than SCALE-EYE measurement
- description
- 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.
- interventionNames
- Device: SCALE-EYE (2)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.