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Search / Trial NCT07005453

Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size

Launched by ERASMUS MEDICAL CENTER · Jun 4, 2025

Trial Information

Current as of July 25, 2025

Not yet recruiting

Keywords

Virtual Scale Endoscopy Biopsy Forceps Optical Assessment Colorectal Cancer

ClinConnect Summary

This clinical trial is studying a new tool called SCALE-EYE, which is designed to help doctors accurately measure the size of polyps found during colonoscopies. Polyps are growths in the colon that can sometimes lead to cancer, so it’s important to monitor and evaluate them carefully. The trial aims to see how well SCALE-EYE works in identifying polyp sizes and whether using this tool can help reduce the number of colonoscopies needed in the future, which would also lessen waste and the environmental impact of these procedures.

To participate in the trial, you need to be between 55 and 80 years old and scheduled for a specific type of colon cancer screening called a fecal immunochemical test (FIT) or a surveillance colonoscopy. You should have polyps that are 25 mm or smaller, as determined by your doctor. If you have certain conditions, like inflammatory bowel disease or if you’re pregnant, you won't be eligible to join. If you decide to participate, you can expect a thorough evaluation of your polyps using the new SCALE-EYE tool during your colonoscopy. The trial is not recruiting participants yet, but it will provide valuable information to improve future colon cancer screenings.

Gender

ALL

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

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported