A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy
A Prospective, Randomized, Single-blind, 2 × 2 Factorial Design Single Center Study Evaluating the Polyp Detection and Quality Monitoring Function of EndoAngel in Improving the Quality of Colonoscopy
1 other identifier
interventional
1,090
1 country
1
Brief Summary
An artificial intelligence-based system, named EndoAngel,has been constructed previously,which has polyp detection and quality monitoring functions. This study aims to evaluate the two different functions of EndoAngle in improving adenoma detection rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedOctober 22, 2020
October 1, 2020
4 months
June 27, 2020
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
3 Months
Secondary Outcomes (12)
Polyp detection rate
3 months
The mean number of polyps per procedure
3 months
The mean number of adenomas per procedure
3 months
Detection rate of large, small and diminutive polyps
3 months
The mean number of large, small and diminutive polyps per procedure
3 months
- +7 more secondary outcomes
Study Arms (4)
Control group
SHAM COMPARATORPatients will receive colonoscopy without assistance of EndoAngel's any function.
Polyp detection function group
EXPERIMENTALPatients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.
Quality monitoring function group
EXPERIMENTALPatients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.
Polyp detection plus quality monitoring functions group
EXPERIMENTALPatients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
Interventions
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.
Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
Eligibility Criteria
You may qualify if:
- Male or female aged 18 years or above;
- Colonoscopy is needed to further characterize gastrointestinal diseases;
- Ability to read, understand and sign informed consent forms;
- 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.
You may not qualify if:
- Participated in other clinical trials, signed informed consent forms and followed up in other clinical trials；
- Participate in a drug clinical trial and during the elution period of the trial or control drug；
- Drug or alcohol abuse or mental disorder in the last 5 years;
- Pregnant or lactating women;
- Patients with multiple polyp syndrome;
- Patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
- Patients with known perforation or colonic obstruction;
- Patients with a contraindication for biopsy;
- The researchers did not consider the subjects suitable for colonoscopy;
- The researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Related Publications (1)
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.
PMID: 34823258DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2020
First Posted
July 1, 2020
Study Start
July 1, 2020
Primary Completion
October 20, 2020
Study Completion
October 30, 2020
Last Updated
October 22, 2020
Record last verified: 2020-10