NCT05500248Completed
Artificial Intelligence for Leaving in Situ Colorectal Polyps.
Impact of Computer-aided Optical Diagnosis (CADx) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial.
Source: ClinicalTrials.gov · Last updated 18 Apr 2025
Brief summary (registry, in English)
This two parallel-arms, randomized, multicenter trial is aimed at investigating safety and effectiveness of a Computer-Aided-Diagnosis (CADx)-assisted leave-in-situ strategy (Leave-In-Situ Arm) as opposed to a resect-all strategy (Standard Arm) as implemented by endoscopists in a real-world setting. With this study it will be possible to understand the impact of CADx in patient treatment and management both in terms of clinical outcome and costs.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 919 (actual)
- First submitted
- 11 Aug 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Roma La Sapienza
- Diseases
- Colorectal cancer
- NCT number
- NCT05500248
What you commit to
- Study type: Interventional
- Participants enrolled: 919
- From 1 Oct 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients with previous colonic resection.
- patients on antithrombotic therapy, precluding polyp resection.
Other illness
- patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).
- Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
Other
- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
- patients who were not able or refused to give informed written consent.
Who the study is looking for
- \- All \>18 years-old patients undergoing elective colonoscopy
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Dei Castelli Coordinator of this site? Confirm its status | Ariccia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.