Back to resultsA Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy
Primary Purpose
Adenoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Colonoscopy with the assistance of EndoAngel's polyp detection function.
Colonoscopy with the assistance of EndoAngel's quality monitoring function.
Colonoscopy without the assistance of EndoAngel's any function.
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma focused on measuring Polyp Detection, Quality Monitoring, Artificial Intelligence
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Renmin Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Sham Comparator
Experimental
Experimental
Experimental
Arm Label
Control group
Polyp detection function group
Quality monitoring function group
Polyp detection plus quality monitoring functions group
Arm Description
Patients will receive colonoscopy without assistance of EndoAngel's any function.
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.
Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Polyp detection rate
The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
The mean number of polyps per procedure
The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
The mean number of adenomas per procedure
The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Detection rate of large, small and diminutive polyps
The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
The mean number of large, small and diminutive polyps per procedure
The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Detection rate of large, small and diminutive adenomas
The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
The mean number of large, small and diminutive adenomas per procedure
The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Detection rate of adenoma in different sites
The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
The mean number of adenomas in different sites per procedure
The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time of colonoscopic insertion
The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening
Time of colonoscopic withdrawal
The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.
Cecal intubation rate
The numerator is the number of cases of colonoscopy reaching ileocecal valve or appendiceal opening, and the denominator is the total number of colonoscopy cases.
Full Information
NCT ID
NCT04453956
First Posted
June 27, 2020
Last Updated
October 19, 2020
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT04453956
Brief Title
A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 20, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renmin Hospital of Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of colon cancer. However, the detection rate of adenomatous polyps can vary significantly among endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp detection and quality monitoring functions. The polyp detection function can remind endoscopists of the location of the polyp. The quality monitoring function can monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.This study aims to evaluate the two different functions of EndoAngle by 2 × 2 factorial design in improving adenoma detection rate and the quality of colonscopy .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
Polyp Detection, Quality Monitoring, Artificial Intelligence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1090 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Patients will receive colonoscopy without assistance of EndoAngel's any function.
Arm Title
Polyp detection function group
Arm Type
Experimental
Arm Description
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function.
Arm Title
Quality monitoring function group
Arm Type
Experimental
Arm Description
Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function.
Arm Title
Polyp detection plus quality monitoring functions group
Arm Type
Experimental
Arm Description
Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function.
Intervention Type
Diagnostic Test
Intervention Name(s)
Colonoscopy with the assistance of EndoAngel's polyp detection function.
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Colonoscopy with the assistance of EndoAngel's quality monitoring function.
Intervention Description
Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
Intervention Type
Diagnostic Test
Intervention Name(s)
Colonoscopy without the assistance of EndoAngel's any function.
Intervention Description
Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Polyp detection rate
Description
The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
Time Frame
3 months
Title
The mean number of polyps per procedure
Description
The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
3 months
Title
The mean number of adenomas per procedure
Description
The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
3 months
Title
Detection rate of large, small and diminutive polyps
Description
The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Time Frame
3 months
Title
The mean number of large, small and diminutive polyps per procedure
Description
The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Time Frame
3 months
Title
Detection rate of large, small and diminutive adenomas
Description
The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Time Frame
3 months
Title
The mean number of large, small and diminutive adenomas per procedure
Description
The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Time Frame
3 months
Title
Detection rate of adenoma in different sites
Description
The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
3 months
Title
The mean number of adenomas in different sites per procedure
Description
The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
3 months
Title
Time of colonoscopic insertion
Description
The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening
Time Frame
3 months
Title
Time of colonoscopic withdrawal
Description
The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.
Time Frame
3 months
Title
Cecal intubation rate
Description
The numerator is the number of cases of colonoscopy reaching ileocecal valve or appendiceal opening, and the denominator is the total number of colonoscopy cases.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Honggang Yu, MD
Phone
+8613871281899
Email
yuhonggang1968@163.com
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honggang Yu, MD
Phone
+8613871281899
Email
yuhonggang1968@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34823258
Citation
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.
Results Reference
derived
Learn more about this trial
A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy
We'll reach out to this number within 24 hrs