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Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using pCLE With Artificial Intelligence

Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using Probe-based Confocal Laser Endomicroscopy With Artificial Intelligence

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04131530
Enrollment
60
Registered
2019-10-18
Start date
2019-10-31
Completion date
2019-12-31
Last updated
2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Confocal Laser Endomicroscopy, Ulcerative Colitis

Brief summary

Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables to evaluate the inflammation activity of ulcerative colitis with excellent correlation with histopathology. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.

Interventions

When the colon mucosa is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* aged between 18 and 80; diagnosed as UC

Exclusion criteria

* Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
The diagnosis efficiency of Artificial Intelligence3 monthsThe primary outcome is to test the diagnostic accuracy, sensitivity, specificity, PPV, NPV of the Artificial Intelligence for evaluation of inflammation activity of UC on pCLE examination.

Secondary

MeasureTime frameDescription
Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists3 monthsThe secondary outcome is to compare the diagnosis efficiency (including diagnostic accuracy, sensitivity, specificity, PPV, NPV ) between Artificial Intelligence and endoscopists.

Countries

China

Contacts

Primary ContactYanqing Li
liyanqing@sdu.edu.cn053182169385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026