Back to resultsA Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
Primary Purpose
Adenoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Colonoscopy with assistance of Endo.Angel
Colonoscopy without assistance of Endo.Angel
Sponsored by
About this trial
This is an interventional screening trial for Adenoma
Eligibility Criteria
Inclusion Criteria:
- Men or women over the age of 18 years old;
- Ability to read, understand and sign informed consent;
- The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all the research procedures and follow-up visits in conjunction with the research procedure.
Exclusion Criteria:
- Colonoscopy patients with absolute contraindications;
- patients with biopsy contraindications;
- inflammatory bowel disease, colorectal cancer, history of colorectal surgery;
- women during pregnancy or lactation;
- Patients with multiple polyposis syndrome;
- Patients with known or suspected intestinal obstruction or perforation
- Previously failed colonoscopy;
- The investigator believes that the subject is not suitable for high-risk disease or other special conditions in clinical trials.
Sites / Locations
- Renmin Hospital of Wuhan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Exposed group
Non-exposed group
Arm Description
Patients will receive colonoscopy with assistance of Endo.Angel
Patients will receive colonoscopy without assistance of Endo.Angel
Outcomes
Primary Outcome Measures
Adenoma detection rate
The numerator is the number of cases of adenoma detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
Secondary Outcome Measures
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.
Polyp Detection Rate
The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients receiving 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 minimal polyps
The numerator was the number of patients with large (≥10 mm), small (4-9 mm), and minimal(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy
The mean number of large, small and minimal polyps per procedure
The numerator was the number of large (≥10 mm), small (4-9 mm), and minimal (≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy
Detection rate of large, small and minimal adenomas
The numerator was the number of patients with large (≥10 mm), small (4-9 mm), and minimal(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy
Full Information
NCT ID
NCT04135716
First Posted
October 20, 2019
Last Updated
October 20, 2019
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT04135716
Brief Title
A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
Official Title
A Prospective, Randomized, Single-blind, Parallel-controlled Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
July 1, 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
Colonoscopy is a key technique in the detection and diagnosis of lower gastrointestinal diseases. High quality endoscopy results in better disease outcomes. However, the operant level of different endoscopists is significantly different.This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to 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.
Detailed Description
This study aims to construct a real-time quality monitoring system based on computer vision, named Endo.Angel, which is used to 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.Criteria for inclusion and exclusion are determined prior to endoscopic examination. Candidates who meet all inclusion criteria as well as do not meet all exclusion criteria are bring into the study. Participants randomized before the examination, they are divided into the exposed group assisted by Endo.Angel or the non-exposed group without Endo.Angel. Followup are conducted after the examination.Study will be finished when all followup is done,and the examination result collected from participants will send to an independent review data analysis group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization results were kept confidential in the general case, and information on the use of EndoAngel was not reflected in the hospital history and documents obtained by other subjects. During the examination and after the examination, researchers should take care to avoid talking to the subjects about random content and avoid unnecessary blindness.
The evaluator was blinded, and neither the data analysis team nor the pathologist could obtain random result information from the medical history data, regardless of whether the subject used EndoAngel or not.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1076 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exposed group
Arm Type
Experimental
Arm Description
Patients will receive colonoscopy with assistance of Endo.Angel
Arm Title
Non-exposed group
Arm Type
Sham Comparator
Arm Description
Patients will receive colonoscopy without assistance of Endo.Angel
Intervention Type
Diagnostic Test
Intervention Name(s)
Colonoscopy with assistance of Endo.Angel
Intervention Description
Patients in exposed group will receive colonoscopy with assistance of Endo.Angel,a real-time quality monitoring system based on computer vision,which is used to 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Colonoscopy without assistance of Endo.Angel
Intervention Description
Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
The numerator is the number of cases of adenoma 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
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
Polyp Detection Rate
Description
The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients receiving 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 minimal polyps
Description
The numerator was the number of patients with large (≥10 mm), small (4-9 mm), and minimal(≤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 minimal polyps per procedure
Description
The numerator was the number of large (≥10 mm), small (4-9 mm), and minimal (≤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 minimal adenomas
Description
The numerator was the number of patients with large (≥10 mm), small (4-9 mm), and minimal(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy
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:
Men or women over the age of 18 years old;
Ability to read, understand and sign informed consent;
The investigator believes that the subject understands the flow of the clinical study and is willing and able to complete all the research procedures and follow-up visits in conjunction with the research procedure.
Exclusion Criteria:
Colonoscopy patients with absolute contraindications;
patients with biopsy contraindications;
inflammatory bowel disease, colorectal cancer, history of colorectal surgery;
women during pregnancy or lactation;
Patients with multiple polyposis syndrome;
Patients with known or suspected intestinal obstruction or perforation
Previously failed colonoscopy;
The investigator believes that the subject is not suitable for high-risk disease or other special conditions in 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
12. IPD Sharing Statement
Learn more about this trial
A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
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