A Multicenter Study Evaluating the Effectiveness of Endo.Angel in Improving the Quality of Colonoscopy

NCT04135716 | Unknown

• 1 other identifier: EA-18-003
• Study Type: interventional
• Target: 1,076
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoma

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months.

Secondary Outcomes (6)

• The mean number of polyps per procedure

  3 months.

• Polyp Detection Rate

  3 months.

• The mean number of adenomas per procedure

  3 months.

• Detection rate of large, small and minimal polyps

  3 months.

• The mean number of large, small and minimal polyps per procedure

  3 months.

Study Arms (2)

Exposed group

EXPERIMENTAL

Patients will receive colonoscopy with assistance of Endo.Angel

Diagnostic Test: Colonoscopy with assistance of Endo.Angel

Non-exposed group

SHAM COMPARATOR

Patients will receive colonoscopy without assistance of Endo.Angel

Diagnostic Test: Colonoscopy without assistance of Endo.Angel

Interventions

Colonoscopy with assistance of Endo.Angel DIAGNOSTIC_TEST

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.

Exposed group

Colonoscopy without assistance of Endo.Angel DIAGNOSTIC_TEST

Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.

Non-exposed group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

MeSH Terms

Conditions

Adenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Honggang Yu, MD

CONTACT

+8613871281899; yuhonggang1968@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 23, 2019
• Study Start: November 28, 2019
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

CN (1)