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
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
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
NCT ID
NCT04087824
First Posted
September 11, 2019
Last Updated
September 11, 2019
Sponsor
Shandong University
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
Learn more about this trial
Deep Learning Algorithm for Recognition of Colonic Segments.
We'll reach out to this number within 24 hrs