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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05145712
Other study ID # EA-21-006
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 21, 2021
Est. completion date March 20, 2022

Study information

Verified date November 2021
Source Renmin Hospital of Wuhan University
Contact Honggang Yu, PhD
Phone 13871281899
Email yuhonggang1969@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To verify the correlation between the proposed artificial intelligence based bowel preparation assessment system and the missed detection rate of adenomas, and to evaluate whether the system can effectively assist doctors in identifying patients who need to be re-examined by colonoscopy due to poor intestinal cleanliness.


Recruitment information / eligibility

Status Recruiting
Enrollment 263
Est. completion date March 20, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: At least 4 operators were included in this study, and the operating years of colonoscopy were = 5 years, and the number of independent operating cases was = 3000. Subjects who meet all of the following specific criteria will be considered for participation in the study: 1. Male or female with age = 45 years inclusive; 2. Able to read, understand and sign informed consent; 3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures. Exclusion Criteria: Subjects who meet any of the following specific criteria will be refused to participate in the study: 1. have a history of drug or alcohol abuse or psychological disorders within the last 5 years; 2. Pregnant or lactating women; 3. Patients with known multiple polyp syndrome; 4. patients with known inflammatory bowel disease; 5. known intestinal stenosis or space-occupying tumor; 6. known colon obstruction or perforation; 7. patients with a history of colorectal surgery; 8. Patients with previous history of allergy to pre-used spasmolysis; 9. Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants; 10. High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Bowel readiness
During the examination, the endoscopic physician required to stay in place while rinsing, and the lens could only be withdrawn after rinsing. During the examination, the recorder should record the time points of the right colon, transverse colon, and left colon, as well as the time of irrigation. If both are considered to be properly, then second colonoscopy was performed immediately. If both results agree or either side agrees that the gut is not well prepared, the review will be carried out within a year

Locations

Country Name City State
China Renmin Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Missed detection rate of =5mm adenoma (= 5mm adenoma missed rate, = 5mm AMR) : Each patient will receive two colonoscopy examinations. The = 5mm adenoma that were not detected in the first colonoscopy was define as missed = 5mm adenoma. Numerator is the number of missed detection of =5mm adenomas during colonoscopy, and denominator is the total number of = 5mm adenomas receiving colonoscopy. 6 months
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