Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
ConditionColorectal Polyps
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-80
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
SCALE-EYE (1)
DeviceParticipants 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 (2)
DeviceParticipants 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.
Treatment groups
241 Participants
are divided into 2 treatment groupsGroup A: SCALE-EYE measurement than biopsy-forceps assisted measurementOther 1 intervention
Group B: Biopsy-forceps assisted measurement than SCALE-EYE measurementOther 1 intervention
Trial outcomes
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.
Time frame
Immediately after the screening and/or surveillance colonoscopySecondary outcomes
1
SCALE-EYE diagnostic performance versus optical assessment
The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment for polyp size measurement. This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to optical assessment.
Time frame
Immediately after the screening and/or surveillance colonoscopy2
Sustainability
The sustainability aspect of SCALE-EYE will be assessed by exploring whether the number of colonoscopies, the colonoscopy-associated waste and carbon footprint will be reduced by correct size measurement.
Time frame
After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)3
Learning curve
The learning curve will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty.
Time frame
Immediately after the screening and/or surveillance colonoscopy4
Surveillance interval agreement
The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard (biopsy-forceps assisted measurement) will be compared.
Time frame
After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy)Other outcomes
1
Endoscopist experience
Endoscopist experience (experienced = \>1000 independent colonoscopies; regular = 300 - 1000)
Time frame
At baseline2
Age
Age in years of participant
Time frame
At baseline (after informed consent is signed)3
Sex
Sex (male/female) of participant
Time frame
At baseline (after informed consent is signed)4
Personal/family history of polyps or colorectal cancer (CRC)
Personal/family history of polyps or colorectal cancer (CRC) of participant - yes or no
Time frame
At baseline (after informed consent is signed)Sponsors and contacts
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Source ClinicalTrials.gov