CClinicalTrials.gg
Status unknownNCT04222439Updated Feb 18, 2020

Deep Learning Algorithm for the Diagnosis of Gastrointestinal Diseases

An interventional study of AI for the Diagnosis of Gastrointestinal Diseases in Gastrointestinal Disease, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-18.

Sponsored by Shandong University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

Read the detailed description

Recently, deep learning algorithm based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. However, there is still a blank in recognition of all gastrointestinal diseases. This study aim to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

02

Conditions studied

  • Gastrointestinal Disease

Keywords

  • Deep Learning
  • Central Neural Networks
  • Endoscopy
  • Gastrointestinal Disease
03

In context

Gastrointestinal Diseases

629 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 76 across 423 interventional studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals.

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100,000 participants (estimated)

Study arms

  • Experimental
    AI monitoring gastrointestinal endoscopy

    After receiving standard preparation regimen, patients go through colonoscopy or gastroscopy under the AI monitoring device. The whole procedure is monitored by AI associated recognition system. Gastrointestinal diseases will be detect and diagnosis in which the AI device will automatically captured relevant images and report the site of each segment on the screen. Histology analysis is set as a golden standard. Then all the AI captured images will be reviewed by human group, which consists of three to five experienced endoscopic physicians.

    Device: AI for the Diagnosis of Gastrointestinal Diseases

Interventions

  • DeviceAI for the Diagnosis of Gastrointestinal Diseases

    After receiving standard preparation regimen, patients go through colonoscopy or gastroscopy under the AI monitoring device. The whole procedure is monitored by AI associated recognition system. Gastrointestinal diseases will be detect and diagnosis in which the AI device will automatically captured relevant images and report the site of each segment on the screen. Histology analysis is set as a golden standard. Then all the AI captured images will be reviewed by human group, which consists of three to five experienced endoscopic physicians.

06

What researchers measure

Primary outcomes

  1. The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.

    The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.

    Time frame: 1 month

Secondary outcomes

  1. The diagnostic sensitivity of gastrointestinal diseases with deep learning algorithm.

    The diagnostic sensitivity of gastrointestinal diseases with deep learning algorithm.

    Time frame: 1 month

  2. The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.

    The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.

    Time frame: 1 month

  3. The diagnostic positive predictive value of gastrointestinal diseases with deep learning algorithm.

    The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.

    Time frame: 1 month

  4. The diagnostic negative predictive value of gastrointestinal diseases with deep learning algorithm.

    The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.

    Time frame: 1month

07

Study locations

1 of 1 sites recruiting
  • Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04222439
Lead sponsor
Shandong University
Responsible party
Xiuli Zuo (director of Qilu Hospital gastroenterology department, Shandong University) — Principal investigator
First posted
Jan 10, 2020
Start date
Jan 1, 2020
Primary completion
Feb 2020 (estimated)
Completion
Feb 2020 (estimated)
Last update
Feb 18, 2020

Study contacts

Xiuli Zuo, MD,PhD
Contact
zuoxiuli@sdu.edu.cn
15588818685
Xiuli Zuo, MD,PhD
principal investigator · Qilu Hospital of Shandong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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