Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps

Colonoscopy Clinical Trial

Official title:

Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps: a Prospective Randomized Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04126265
• Other study ID #: NCT201908-K5-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: December 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: YI zhang, master degree
• Phone: +86 13533787871
• Email: 13533787871[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: August 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Artificial Intelligence
• Colonic Polyps
• Colonoscopy

Intervention

Device:
• Artificial intelligence assisted colonoscopy
The colonoscopy is connected to the real-time polyp detection system. If the polyp is detected by enteroscopy, the alarm will be given.

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Side Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Number of polyps detected	Number of polyps found in each group.	6 months
Secondary	Polyp size	Average size of all polyps detected in each group.	6 months
Secondary	Polyp morphology	Morphological classification of all polyps detected in each group.	6 months