Trials / Completed
CompletedNCT04884581
Characterization of Colorectal Neoplasia
The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Nuovo Regina Margherita Hospital · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GI Genius CADx device | GI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma. |
Timeline
- Start date
- 2021-05-12
- Primary completion
- 2021-07-01
- Completion
- 2021-08-05
- First posted
- 2021-05-13
- Last updated
- 2021-08-06
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04884581. Inclusion in this directory is not an endorsement.