NCT07005453 Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
| NCT ID | NCT07005453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Colorectal Polyps |
| Study Type | INTERVENTIONAL |
| Enrollment | 241 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 241 participants in total. It began in 2025-09-23 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT07005453 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 80 Years, studying Colorectal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07005453 currently recruiting?
Yes, NCT07005453 is actively recruiting participants. Visit ClinicalTrials.gov or contact Erasmus Medical Center to inquire about joining.
Where is the NCT07005453 trial being conducted?
This trial is being conducted at Eindhoven, Netherlands, Leiden, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT07005453 clinical trial?
NCT07005453 is sponsored by Erasmus Medical Center. The trial plans to enroll 241 participants.