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Development and Validation of a Deep Learning Algorithm to Evaluate Endoscopic Disease Activity of Ulcerative Colitis.

NCT03973437 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-06-04

No results posted yet for this study

Summary

The purpose of this study is to develop an artificial intelligence(AI) assisted scoring system, which can evaluate the disease severity and mucosal healing stage in patients with ulcerative colitis. Then testify whether this new scoring system can help physicians to enhance the accuracy of disease severity assessments in a multi-center clinical practice.

Conditions

Interventions

DEVICE

Artificial inteligence associated ulcerative colitis severity scoring system

Patients in this group go through a flexible colonoscopy under the AI monitoring device. During the withdrawal process, inflammatory lesions are detected by AI-associated scoring system. Pictures are automatically captured and analyzed by the computer. The Mayo ES and UCEIS sores will be calculated and presented on a second screen, providing a reference for the physician to evaluate the disease severity and mucosal healing stage of the patient. Biopsies will be taken from inflammatory region for histological examination. Videos will be recorded and re-evaluated by a group of experts to determine the final Mayo ES and UCEIS scores.

DEVICE

Conventional human scoring

Patients in this group go through a conventional colonoscopy without the AI monitoring device. During the withdrawal process, physician evaluates the disease severity and mucosal healing stage of the patient according to his personal experience. Biopsies will be taken from inflammatory region for histological examination. Videos will be recorded and re-evaluated by a group of experts to determine the final Mayo ES and UCEIS scores.

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Principal Investigators

  • Xiuli Zuo, MD,PhD · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-12-31
Completion
2020-06-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03973437 on ClinicalTrials.gov