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
Qualifiers
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
Treatments tested in this trial
- SCALE-EYE (1)
- SCALE-EYE (2)
Treatment groups
241 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov