Back to resultsA Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
Primary Purpose
Adenoma Detection Rate
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 diagnostic trial for Adenoma Detection Rate focused on measuring colonoscopy, computer vision, adenoma detection rate, Endo.Angel
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 known space-occupying tumor or intestinal stenosis;
- Patients with known perforation or colonic obstruction;
- A history of anaphylaxis with antispasmodic has been documented;
- 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 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
The mean number of large, small and minimal adenomas per procedure
The numerator was the number of 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.
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 withdrawal
the duration of colonoscopic withdrawal(not include the time of biopsy or treatment).
Time of colonoscopic insertion
The time of colonoscopy from the rectum to the ileocecal area.
The rate of reaching the ileocecal region
The numerator is the number of cases of colonic examination reaching the ileocecal region, and the denominator is the total number of colonoscopy cases.
Full Information
NCT ID
NCT04102631
First Posted
September 23, 2019
Last Updated
September 23, 2019
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT04102631
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
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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 Detection Rate
Keywords
colonoscopy, computer vision, adenoma detection rate, Endo.Angel
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Title
The mean number of large, small and minimal adenomas per procedure
Description
The numerator was the number of 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
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 withdrawal
Description
the duration of colonoscopic withdrawal(not include the time of biopsy or treatment).
Time Frame
3 months
Title
Time of colonoscopic insertion
Description
The time of colonoscopy from the rectum to the ileocecal area.
Time Frame
3 months
Title
The rate of reaching the ileocecal region
Description
The numerator is the number of cases of colonic examination reaching the ileocecal region, 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 known space-occupying tumor or intestinal stenosis;
Patients with known perforation or colonic obstruction;
A history of anaphylaxis with antispasmodic has been documented;
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
Learn more about this trial
A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy
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