A post-approval, randomized, double-blind trial comparing the effectiveness and safety of submucosal injection with Eleview® vs saline with methylene blue was performed in patients undergoing EMR of treatment-naïve polyps or adenomas of the colon > 20 mm.
- 211 patients
- Eleview® (n =102)
- Comparator (n=109)
- Sites’ standard of care: A mixture of normal saline and methylene blue
- Total injected volume needed to complete the EMR procedure
- Total injected volume per lesion size
- Time to resect the lesion completely
- Complication and adverse event occurrence during and after the procedure
Secondary endpoints were also explored.