Clinical trial NCT07005453: Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
Official title: Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Polyps
Keywords: virtual scale endoscopy
biopsy forceps
optical assessment
colorectal cancer
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 241
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: SCALE-EYE diagnostic performance versus biopsy-forceps
timeFrame: Immediately after the screening and/or surveillance colonoscopy
Secondary outcomes:
measure: SCALE-EYE diagnostic performance versus optical assessment
timeFrame: Immediately after the screening and/or surveillance colonoscopy
measure: Sustainability
timeFrame: After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)
measure: Learning curve
timeFrame: Immediately after the screening and/or surveillance colonoscopy
measure: Surveillance interval agreement
timeFrame: After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)
measure: (Serious) adverse events
timeFrame: Up to 30 days post-colonoscopy
Other outcomes:
measure: Endoscopist experience
timeFrame: At baseline
measure: Age
timeFrame: At baseline (after informed consent is signed)
measure: Sex
timeFrame: At baseline (after informed consent is signed)
measure: Personal/family history of polyps or colorectal cancer (CRC)
timeFrame: At baseline (after informed consent is signed)
measure: Type of colonoscopy
timeFrame: At baseline (after informed consent is signed)
measure: Type of endoscope used
timeFrame: During the screening and/or surveillance colonoscopy
measure: Sedation
timeFrame: During the screening and/or surveillance colonoscopy
measure: Use of butyl scopolamine
timeFrame: During the screening and/or surveillance colonoscopy
measure: Boston Bowel Preparation Score (BBPS)
timeFrame: During the screening and/or surveillance colonoscopy
measure: Cecum intubation rate
timeFrame: At baseline
measure: Polyp information
timeFrame: During the screening and/or surveillance colonoscopy
measure: Time needed for measurement
timeFrame: During the screening and/or surveillance colonoscopy
measure: Experienced difficulty
timeFrame: During the screening and/or surveillance colonoscopy
measure: Reason of unsuccessful SCALE-EYE measurement
timeFrame: During the screening and/or surveillance colonoscopy
measure: Withdrawal time
timeFrame: Immediately after the screening and/or surveillance colonoscopy
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