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

NCT ID: NCT07005453

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-23
• Study Completion Date: 2026-04-01

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.

Detailed Description

Objective: This study aims to assess the diagnostic performance of SCALE-EYE in a screening and surveillance colonoscopy population. Also, sustainability of SCALE-EYE in terms of the reduction in colonoscopies, associated waste and carbon footprint is evaluated.

Study design: A multicenter, randomized, parallel group, endoscopist blinded study.

Study population: The unit of analysis is the colorectal polyp rather than the participants, approximately 289 colorectal polyps are planned to be included. Based on an expected detection rate of roughly 1.20 polyps per colonoscopy in the study population, approximately 241 participants aged 55-80 years old, who are referred for screening or surveillance colonoscopy at the participating study sites and have signed the informed consent form (ICF), will be included into the study. Polyps of all shapes (flat, sessile, pedunculated) that are found during colonoscopy and are smaller than 25 mm, as judged by the endoscopist using optical assessment, are considered eligible for inclusion.

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

Primary outcome measurement: 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.

Secondary outcome measurements:

• The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment by endoscopists for polyp size measurement.
• Sustainability (reduction of colonoscopies, the colonoscopy-associated waste and carbon footprint).
• The learning curve, this will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty.
• The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard.
• Safety, in terms of (serious) adverse events up to 30 days post-procedure.

Conditions

Colorectal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

SCALE-EYE measurement than biopsy-forceps assisted measurement

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.

Group Type: OTHER

SCALE-EYE (1)

Intervention Type: 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.

Biopsy-forceps assisted measurement than SCALE-EYE measurement

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.

Group Type: OTHER

SCALE-EYE (2)

Intervention Type: 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.

Interventions

SCALE-EYE (1)

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.

Intervention Type: DEVICE

SCALE-EYE (2)

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Peter Siersema

Prof. Dr. P.D. Siersema

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Site Status: RECRUITING

LUMC

Leiden, South Holland, Netherlands

Site Status: RECRUITING

Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Ramon-Michel Schreuder, Dr.

Role: primary

ramonmichel.schreuder@catharinaziekenhuis.nl

+31 40 2399750

Jurjen Boonstra, Dr.

Role: primary

j.j.boonstra@lumc.nl

+31 71 5263575

Demi Gerritsen, MSc

Role: primary

d.gerritsen@erasmusmc.nl

+31 650033985

Other Identifiers

MEC-2024-0789

Identifier Type: -

Identifier Source: org_study_id