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Deep Learning Algorithm for Recognition of Colonic Segments.

Primary Purpose

Colonic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AI assisted recognition of colonic segments
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colonic Diseases focused on measuring Deep learning, Colonoscopy, Central Neural Networks

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-70 years undergoing conventional colonoscopy

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    AI monitoring colonoscopy

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 11, 2019
    Last Updated
    September 11, 2019
    Sponsor
    Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04087824
    Brief Title
    Deep Learning Algorithm for Recognition of Colonic Segments.
    Official Title
    Development and Validation of a Deep Learning Algorithm for Real-time Recognition of Colonic Segments.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2019 (Anticipated)
    Primary Completion Date
    November 15, 2019 (Anticipated)
    Study Completion Date
    December 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shandong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colonic Diseases
    Keywords
    Deep learning, Colonoscopy, Central Neural Networks

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AI monitoring colonoscopy
    Arm Type
    Experimental
    Arm Description
    Patients in this group go through colonoscopy under the AI monitoring device.
    Intervention Type
    Device
    Intervention Name(s)
    AI assisted recognition of colonic segments
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The accuracy of each colonic segment real-time recognition with deep learning algorithm.
    Description
    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 Outcome Measure Information:
    Title
    The accuracy of total colonic segments recognition with deep learning algorithm as compared to endoscopic experts group.
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18-70 years undergoing conventional colonoscopy 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiuli Zuo, MD,PhD
    Phone
    15588818685
    Email
    zuoxiuli@sdu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiuli Zuo, MD,PhD
    Organizational Affiliation
    Qilu Hospital of Shandong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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