CClinicalTrials.gg
Status unknownNCT04087824Updated Sep 12, 2019

Deep Learning Algorithm for Recognition of Colonic Segments.

An interventional study of AI assisted recognition of colonic segments in Colonic Diseases, sponsored by Shandong University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Shandong University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study summary

The purpose of this study is to develop and validate a deep learning algorithm to realize automatic recognition of colonic segments under conventional colonoscopy. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

Read the detailed description

Colonoscopy is recommended as a routine examination for colorectal cancer screening. Complete inspection of all colon segments is the basis of colonoscopy quality control, and furthermore improves the detection rates of small adenomas. 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 anatomic sites, which restricts the realization of AI-aided lesions detection and disease severity scoring. This study aim to train an algorithm to recognize key colonic segments, and testify the accuracy of each segments recognition as compared to endoscopic physicians.

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Conditions studied

  • Colonic Diseases

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Keywords

  • Deep learning
  • Colonoscopy
  • Central Neural Networks
03

In context

Colonic Diseases

142 studies on the registry are indexed under Colonic Diseases; 22 are open to participants now.

This study's planned enrollment of 60 is below the median of 143 across 93 interventional studies indexed under Colonic Diseases.

Browse Colonic 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.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged 18-70 years undergoing conventional colonoscopy

Exclusion criteria

Exclusion Criteria:

  • Known or suspected bowel obstruction, stricture or perforation
  • Compromised swallowing reflex or mental status
  • Severe chronic renal failure(creatinine clearance \< 30 ml/min)
  • Severe congestive heart failure (New York Heart Association class III or IV)
  • Uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)
  • Dehydration
  • Disturbance of electrolytes
  • Pregnancy or lactation
  • Hemodynamically unstable
  • Unable to give informed consent
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    AI monitoring colonoscopy

    Patients in this group go through colonoscopy under the AI monitoring device.

    Device: AI assisted recognition of colonic segments

Interventions

  • DeviceAI assisted recognition of colonic segments

    After receiving standard bowel preparation regimen, patients go through colonoscopy under the AI monitoring device. The whole withdrawal process is monitored by AI associated recognition system. Key colonic segments include ileocecal valve, ascending colon, transverse colon, descending colon, sigmoid colon and rectum. When typical anatomic sites are detected, the AI device will automatically captured relevant images and report the name of each segment on the screen. The operating endoscopy expert will give the final answer and judge the performance of AI, which 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.

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What researchers measure

Primary outcomes

  1. The accuracy of each colonic segment real-time recognition with deep learning algorithm.

    The segmental recognition accuracy is the proportion of correctly recognized segments divided by the number of involved patients. The accuracy rate of ileocecal valve, ascending colon, transverse colon, descending colon, sigmoid colon and rectum will be separately calculated.

    Time frame: 3 months.

Secondary outcomes

  1. The accuracy of total colonic segments recognition with deep learning algorithm as compared to endoscopic experts group.

    The total recognition accuracy is the proportion of correctly recognized images divided by the number of AI captured images. Then all AI captured images will be reviewed by experts group to give a human evaluating rate. Two rates will be compared by student t test to analyze the difference.

    Time frame: 3 months.

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, 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
NCT04087824
Lead sponsor
Shandong University
Responsible party
Xiuli Zuo (director of Qilu Hospital gastroenterology department, Shandong University) — Principal investigator
First posted
Sep 12, 2019
Start date
Sep 15, 2019 (estimated)
Primary completion
Nov 15, 2019 (estimated)
Completion
Dec 15, 2019 (estimated)
Last update
Sep 12, 2019

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 Sep 2019. You cannot join it, but the record below documents what was studied.

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