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

NCT07005453 | Recruiting

• 1 other identifier: MEC-2024-0789
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Polyps

Keywords

virtual scale endoscopy; biopsy forceps; optical assessment; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• SCALE-EYE diagnostic performance versus biopsy-forceps

  The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard.

  Immediately after the screening and/or surveillance colonoscopy

Secondary Outcomes (5)

• SCALE-EYE diagnostic performance versus optical assessment

  Immediately after the screening and/or surveillance colonoscopy

• Sustainability

  After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)

• Learning curve

  Immediately after the screening and/or surveillance colonoscopy

• Surveillance interval agreement

  After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)

• (Serious) adverse events

  Up to 30 days post-colonoscopy

Other Outcomes (15)

• Endoscopist experience

  At baseline

• Age

  At baseline (after informed consent is signed)

• Sex

  At baseline (after informed consent is signed)

Study Arms (2)

SCALE-EYE measurement than biopsy-forceps assisted measurement

OTHER

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.

Device: SCALE-EYE (1)

Biopsy-forceps assisted measurement than SCALE-EYE measurement

OTHER

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.

Device: SCALE-EYE (2)

Interventions

SCALE-EYE (1) DEVICE

Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement.

SCALE-EYE measurement than biopsy-forceps assisted measurement

SCALE-EYE (2) DEVICE

Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE.

Biopsy-forceps assisted measurement than SCALE-EYE measurement

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (3)

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

LUMC

Leiden, South Holland, 2333 ZG, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. P.D. Siersema

Model Details: Participants will be split in two groups who will in parallel to each other undergo both SCALE-EYE measurement and biopsy-forceps assisted measurement, but there will be randomization in the order of measuring. So approximately half of the participants, in whom polyps are found, will first undergo SCALE-EYE measurement and then biopsy-forceps assisted measurement, and the other half of the participants will first undergo biopsy-forceps assisted measurement and then SCALE-EYE measurement.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: June 5, 2025
• Study Start: September 23, 2025
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

NL (3)