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Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps

Primary Purpose

Artificial Intelligence, Colonoscopy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Artificial intelligence assisted colonoscopy
Sponsored by
Side Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Artificial Intelligence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Chinese population aged 18-80 years old; Patients voluntarily signed informed consent form; In accordance with the indications of colonoscopy.

Exclusion Criteria:

(IBD) history of inflammatory bowel disease; History of colorectal surgery; Previous failed colonoscopy; Polyposis syndrome; Highly suspected colorectal cancer (CRC)

Sites / Locations

  • Nanfang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine colonoscopy group

Artificial intelligence assisted colonoscopy group

Arm Description

The patient underwent routine colonoscopy.

The real-time automatic polyp detection system was used to assist the endoscopist.

Outcomes

Primary Outcome Measures

Detection rate of small polyps (diameter < 6mm)
In each group, the number of patients with small polyps was detected as a percentage of the total number of patients.

Secondary Outcome Measures

Number of polyps detected
Number of polyps found in each group.
Polyp size
Average size of all polyps detected in each group.
Polyp morphology
Morphological classification of all polyps detected in each group.

Full Information

First Posted
October 11, 2019
Last Updated
December 30, 2019
Sponsor
Side Liu
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1. Study Identification

Unique Protocol Identification Number
NCT04126265
Brief Title
Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps
Official Title
Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps: a Prospective Randomized Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Side Liu

4. Oversight

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

5. Study Description

Brief Summary
All subjects shall sign informed consent before screening, and subjects shall be included according to inclusion and exclusion criteria. A total of four endoscopists were included in the study, two in each group of senior endoscopists and two in each group of junior endoscopists. Patients were randomly enrolled into the senior endoscopy group and the junior endoscopy group, and received artificial intelligence assisted colonoscopy and conventional colonoscopy successively. The two colonoscopy methods were performed back to back by different endoscopy physicians with the same seniority. All patients were examined and treated according to routine medical procedures. The routine colonoscopy group and the artificial-intelligence-assisted colonoscopy group made detailed records of the patients' withdrawal time, entry time, number of polyps detected, polyp Paris classification, polyp size, polyp shape, polyp location and intestinal preparation during the colonoscopy process
Detailed Description
This is a prospective randomized clinical study.This study was conducted in the Endoscopy Center of the Nanfang Hospital, China. Routine bowel preparation consisted of 4 L of polyethylene glycol, given in split doses. Colonoscopies were performed with high definition colonoscopes and high-definition monitors. All subjects shall sign informed consent before screening, and subjects shall be included according to inclusion and exclusion criteria. A total of four endoscopists were included in the study, two in each group of senior endoscopists (>1000 colonoscopies) and two in each group of junior endoscopists ( <1000 colonoscopies). Patients were randomly enrolled into the senior endoscopy group and the junior endoscopy group, and received artificial intelligence assisted colonoscopy and conventional colonoscopy successively. The two colonoscopy methods were performed by different endoscopy physicians back to back with the same seniority. All patients were examined and treated according to routine medical procedures (outpatient patients and inpatients who did not sign the consent form for polypectomy were not resected for the lesions detected during the examination, while inpatients who signed the consent form for polypectomy were left in the original position after the first colonoscopy and removed at the end of the second examination). The routine colonoscopy group and the artificial-intelligence-assisted colonoscopy group made detailed records of the patients' withdrawal time, entry time, number of polyps detected, polyp Paris classification, polyp size, polyp shape, polyp location and intestinal preparation during the colonoscopy process.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial Intelligence, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine colonoscopy group
Arm Type
No Intervention
Arm Description
The patient underwent routine colonoscopy.
Arm Title
Artificial intelligence assisted colonoscopy group
Arm Type
Experimental
Arm Description
The real-time automatic polyp detection system was used to assist the endoscopist.
Intervention Type
Device
Intervention Name(s)
Artificial intelligence assisted colonoscopy
Intervention Description
The colonoscopy is connected to the real-time polyp detection system. If the polyp is detected by enteroscopy, the alarm will be given.
Primary Outcome Measure Information:
Title
Detection rate of small polyps (diameter < 6mm)
Description
In each group, the number of patients with small polyps was detected as a percentage of the total number of patients.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of polyps detected
Description
Number of polyps found in each group.
Time Frame
6 months
Title
Polyp size
Description
Average size of all polyps detected in each group.
Time Frame
6 months
Title
Polyp morphology
Description
Morphological classification of all polyps detected in each group.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Chinese population aged 18-80 years old; Patients voluntarily signed informed consent form; In accordance with the indications of colonoscopy. Exclusion Criteria: (IBD) history of inflammatory bowel disease; History of colorectal surgery; Previous failed colonoscopy; Polyposis syndrome; Highly suspected colorectal cancer (CRC)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YI zhang, master degree
Phone
+86 13533787871
Email
13533787871@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
side liu, doctor degree
Organizational Affiliation
Chief physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YI ZHANG, master degree
Phone
+86 13533787871

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32968933
Citation
Luo Y, Zhang Y, Liu M, Lai Y, Liu P, Wang Z, Xing T, Huang Y, Li Y, Li A, Wang Y, Luo X, Liu S, Han Z. Artificial Intelligence-Assisted Colonoscopy for Detection of Colon Polyps: a Prospective, Randomized Cohort Study. J Gastrointest Surg. 2021 Aug;25(8):2011-2018. doi: 10.1007/s11605-020-04802-4. Epub 2020 Sep 23.
Results Reference
derived

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Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps

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