Ulcerative Colitis Clinical Trial
— CUDISIAOfficial title:
Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study
| NCT number | NCT05171634 |
| Other study ID # | CEIm: 62.21 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 5, 2021 |
| Est. completion date | May 18, 2021 |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | May 18, 2021 |
| Est. primary completion date | May 18, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Antonio López-Serrano | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana | University of Valencia |
Spain,
Lopez-Serrano A, Voces A, Lorente JR, Santonja FJ, Algarra A, Latorre P, Del Pozo P, Paredes JM. Artificial intelligence for dysplasia detection during surveillance colonoscopy in patients with ulcerative colitis: A cross-sectional, non-inferiority, diagn — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | "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. | Immediately after the procedure. | |
| Primary | "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. | Immediately after the procedure. |
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