Colorectal adenomas and serrated polyps Cancer
Conditions
Interventions
The EndoRings is a flexible silicone rubber add-on device designed to be attached to the distal tip of the designated endoscope. The product features a short tube like shape with two flexible circular
Sponsors
ASL RM1
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects positive at immunochemical fecal test at organized screening program in countries where organized programs are running 2. Sporadic screening in those countries where programs are not running
Exclusion criteria
Exclusion criteria: Previous colonoscopy in 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of (advanced) neoplasia with and without EndoRIng (95% CI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Detection rate of adenoma/polyp/flat adenoma/serrated polyps/adenomas, determined though colonoscopy results from each of the study arms 2. Detection rate of neoplasia by colonic site: distal (rectum, sigmoid and descending colon) and proximal (proximal to the descending colon) 3. Time required to reach the cecum, as measured in minutes during the insertion of the scope from the anus to the caecum 4. Withdrawal time, as measured in minutes during the withdrawal of the scope from the caecum to the anus 5. Patient’s experience, as measured with a visual analogue scale rated from 1 to 7 | — |
Countries
Italy, Netherlands, Spain
Contacts
Public ContactCesare Hassan
Outcome results
None listed