A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy
NCT ID: NCT04453956
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1090 participants
INTERVENTIONAL
2020-07-01
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
DOUBLE
Study Groups
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Control group
Patients will receive colonoscopy without assistance of EndoAngel's any function.
Colonoscopy without the assistance of EndoAngel's any function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
Polyp detection function group
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.
Colonoscopy with the assistance of EndoAngel's polyp detection function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.
Quality monitoring function group
Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.
Colonoscopy with the assistance of EndoAngel's quality monitoring function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
Polyp detection plus quality monitoring functions group
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
Colonoscopy with the assistance of EndoAngel's polyp detection function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.
Colonoscopy with the assistance of EndoAngel's quality monitoring function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
Interventions
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Colonoscopy with the assistance of EndoAngel's polyp detection function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.
Colonoscopy with the assistance of EndoAngel's quality monitoring function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
Colonoscopy without the assistance of EndoAngel's any function.
Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
Eligibility Criteria
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Inclusion Criteria
2. Colonoscopy is needed to further characterize gastrointestinal diseases;
3. Ability to read, understand and sign informed consent forms;
4. The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.
Exclusion Criteria
2. Participate in a drug clinical trial and during the elution period of the trial or control drug；
3. Drug or alcohol abuse or mental disorder in the last 5 years;
4. Pregnant or lactating women;
5. Patients with multiple polyp syndrome;
6. Patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
7. Patients with known perforation or colonic obstruction;
8. Patients with a contraindication for biopsy;
9. The researchers did not consider the subjects suitable for colonoscopy;
10. The researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.
18 Years
ALL
Yes
Sponsors
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Renmin Hospital of Wuhan University
OTHER
Responsible Party
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Locations
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Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yao L, Zhang L, Liu J, Zhou W, He C, Zhang J, Wu L, Wang H, Xu Y, Gong D, Xu M, Li X, Bai Y, Gong R, Sharma P, Yu H. Effect of an artificial intelligence-based quality improvement system on efficacy of a computer-aided detection system in colonoscopy: a four-group parallel study. Endoscopy. 2022 Aug;54(8):757-768. doi: 10.1055/a-1706-6174. Epub 2022 Feb 4.
Other Identifiers
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EA-19-001
Identifier Type: -
Identifier Source: org_study_id
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