Back to resultsArtificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study) (CUDISIA)
Primary Purpose
Ulcerative Colitis, Dysplasia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
DiscoveryTM
iSCAN
Sponsored by
About this trial
This is an interventional screening trial for Ulcerative Colitis focused on measuring Virtual chromoendoscopy, Artificial intelligence, iSCAN, Dysplasia
Eligibility Criteria
Inclusion Criteria:
- Ulcerative Colitis confirmed by endoscopy and histology.
- Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
- Duration of the disease >7 years (or any duration if concomitant with PSC).
Exclusion Criteria:
- Personal history of colorectal cancer or high-grade dysplasia.
- Previous colectomy (partial or complete).
- Coagulopathy that prevents biopsies or polypectomy.
- Colonoscopy performed in the previous 6 months.
- Pregnant or nursing women.
- Inadequate bowel preparation.
- Presence of endoscopic Ulcerative Colitis activity.
- Colonic stenosis and incomplete colonoscopy.
Sites / Locations
- Antonio López-Serrano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Colonoscopy assisted by DiscoveryTM
Virtual Colonoscopy with iSCAN
Arm Description
Outcomes
Primary Outcome Measures
"Per lesion" dysplasia detection rate (DDR)
Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.
"Per patient" dysplasia detection rate (DDR)
Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.
Secondary Outcome Measures
Full Information
NCT ID
NCT05171634
First Posted
June 16, 2021
Last Updated
December 17, 2021
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Collaborators
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT05171634
Brief Title
Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)
Acronym
CUDISIA
Official Title
Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Collaborators
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Dysplasia
Keywords
Virtual chromoendoscopy, Artificial intelligence, iSCAN, Dysplasia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colonoscopy assisted by DiscoveryTM
Arm Type
Experimental
Arm Title
Virtual Colonoscopy with iSCAN
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
DiscoveryTM
Intervention Description
Colonoscopy assisted by an artificial intelligence system (DiscoveryTM).
Intervention Type
Device
Intervention Name(s)
iSCAN
Intervention Description
Virtual colonoscopy assisted by iSCAN
Primary Outcome Measure Information:
Title
"Per lesion" dysplasia detection rate (DDR)
Description
Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.
Time Frame
Immediately after the procedure.
Title
"Per patient" dysplasia detection rate (DDR)
Description
Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.
Time Frame
Immediately after the procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ulcerative Colitis confirmed by endoscopy and histology.
Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
Duration of the disease >7 years (or any duration if concomitant with PSC).
Exclusion Criteria:
Personal history of colorectal cancer or high-grade dysplasia.
Previous colectomy (partial or complete).
Coagulopathy that prevents biopsies or polypectomy.
Colonoscopy performed in the previous 6 months.
Pregnant or nursing women.
Inadequate bowel preparation.
Presence of endoscopic Ulcerative Colitis activity.
Colonic stenosis and incomplete colonoscopy.
Facility Information:
Facility Name
Antonio López-Serrano
City
Valencia
ZIP/Postal Code
46017
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)
We'll reach out to this number within 24 hrs