Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size
Recruiting · NCT07005453 · Interventional (participants receive a specific treatment) · Lead sponsor: Erasmus Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
SCALE-EYE (1)SCALE-EYE (2)
What this trial is 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.
Who can take part
Age range
55 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed.
- Catharina Ziekenhuis - Eindhoven, North Brabant, Netherlands
- LUMC - Leiden, South Holland, Netherlands
- Erasmus MC - Rotterdam, South Holland, Netherlands