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

Erasmus University

Status: Enrolling

Conditions: Colorectal Polyps

Treatments: Device: SCALE-EYE (2); Device: SCALE-EYE (1)

Study type: Interventional

Funder types: Other

Identifiers

NCT07005453

MEC-2024-0789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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241 participants in 2 patient groups

SCALE-EYE measurement than biopsy-forceps assisted measurement

Other group

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.

Treatment:

Device: SCALE-EYE (1)

Biopsy-forceps assisted measurement than SCALE-EYE measurement

Other group

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.

Treatment:

Device: SCALE-EYE (2)