NCT04102631

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,076

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

September 23, 2019

Last Update Submit

September 23, 2019

Conditions

Adenoma Detection Rate

Keywords

colonoscopycomputer visionadenoma detection rateEndo.Angel

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 (12)

  • 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

  • +7 more secondary outcomes

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.AngelDIAGNOSTIC_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.AngelDIAGNOSTIC_TEST

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

non-exposed group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Honggang Yu, MD

CONTACT

+8613871281899yuhonggang1968@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Gastroenterology

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 25, 2019

Study Start

August 30, 2019

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

CN(1)