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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05444166
Other study ID # EA-22-020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 29, 2022
Est. completion date November 29, 2023

Study information

Verified date March 2023
Source Renmin Hospital of Wuhan University
Contact Honggang Yu, Doctor
Phone 8613871281899
Email yuhonggang@whu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, the investigators used the optical flow method to measure the colonoscopy withdrawal speed, and doctors were selected from multiple hospitals to collect prospective colonoscopy screening videos, and the percentage of colonoscopy withdrawal overspeed was calculated to explore the relationship between it based on optical flow method and the adenoma detection rate.


Description:

Study showed that adequate withdrawal time is an important prerequisite for full mucosal inspection. In a large population-based analysis, a 1-min increase in withdrawal time led to a 3.6% increase in the ADR. Protocols or expert consensus recommend a standard withdrawal time of 6 min or longer. However, Findings of studies showed that a number of colonoscopies had a withdrawal time less than 6 min, which greatly reduces the ADR. Investigator's preliminary experiments have shown that deep learning can monitor the colonoscopy withdrawal time in real-time and improve the adenoma detection rate. Based on the above rich foundation of preliminary work and the massive demand for improving the colonoscopy withdrawal assessment system. The investigators improved EndoAngel to use optical flow method to monitor the colonoscopy withdrawal speed. The performance of the EndoAngel system was verified in colonoscopy videos. The investigators then aimed to evaluate whether the EndoAngel system could improve polyp detection rate after restricting the colonoscopy withdrawal speed.


Recruitment information / eligibility

Status Recruiting
Enrollment 550
Est. completion date November 29, 2023
Est. primary completion date October 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female =18 years old; 2. Able to read, understand and sign an 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; 4. Patients requiring screening colonoscopy. Exclusion Criteria: 1. Have drug or alcohol abuse or mental disorder in 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 a 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


Locations

Country Name City State
China Renmin Hospital Hubei 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 The adenoma detection rate (ADR) ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies. A month
Primary The percentage of colonoscopy withdrawal overspeed The percentage of colonoscopy withdrawal overspeed was calculated by dividing the time of colonoscopy withdrawal overspeed by the total time of colonoscopy withdrawal. A month
Secondary The polyp detection rate (PDR) PDR was calculated by dividing the total number of patients being detected polyps by the number of colonoscopies. A month
Secondary The mean number of polyps per patient (MNP) MNP was calculated by dividing the total number of polyps by the number of colonoscopies. A month
Secondary The mean number of adenomas per patient (MAP) MAP was calculated by dividing the total number of adenomas by the number of colonoscopies. A month
Secondary colonoscopy withdrawal time The time is taken to finish the examination from the beginning of the ileocecal region. A month
Secondary colonoscopy forward time The time is taken to go from the rectum to the ileocecal region. A month
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