NCT05323279

Brief Summary

In this study, the AI-assisted system EndoAngel has the functions of reminding the ileocecal junction, withdrawal time, withdrawal speed, sliding lens, polyps in the field of vision, etc. These functions can assist novice endoscopists in performing colonoscopy and improve the quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
685

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 1, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

March 24, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2022

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

March 1, 2022

Last Update Submit

March 22, 2023

Conditions

ColonoscopyArtificial IntelligenceGastrointestinal DiseaseDeep Learning

Outcome Measures

Primary Outcomes (1)

  • Missed diagnosis rate of adenoma

    The number of newly detected adenoma in the second examination divided by the total number of adenoma detected in both examinations

    A month

Secondary Outcomes (10)

  • Detection rate of advanced adenoma

    A month

  • Polyp Detection Rate

    A month

  • Average number of adenomas detected per patient

    A month

  • The detection rate of large, small and micro polyps

    A month

  • The average number of large, small and micro polyps detected

    A month

  • +5 more secondary outcomes

Study Arms (3)

novices with AI-assisted system

EXPERIMENTAL

The novice doctors are assisted in colonoscopy with an artificial intelligence system that can indicate abnormal lesions and the speed of withdrawal in real-time, as well as feedback on the percentage of overspeed.

Device: artificial intelligence assistance system

experts without AI-assisted system

NO INTERVENTION

The expert doctors perform routine colonoscopy without artificial intelligence assistance system and no special tips

novice without AI-assisted system

NO INTERVENTION

The novice doctors perform routine colonoscopy without artificial intelligence assistance system and no special tips

Interventions

artificial intelligence assistance systemDEVICE

The artificial intelligence assistance system can indicate abnormal lesions and real-time withdrawal speed and feedback the overspeed percentage.

novices with AI-assisted system

Eligibility Criteria

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

You may qualify if:

  • Male or female ≥18 years old;
  • Able to read, understand and sign an informed consent;
  • The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
  • Patients requiring colonoscopy.

You may not qualify if:

  • Have drug or alcohol abuse or mental disorder in the last 5 years;
  • Pregnant or lactating women;
  • Patients with known multiple polyp syndrome;
  • patients with known inflammatory bowel disease;
  • known intestinal stenosis or space-occupying tumor;
  • known colon obstruction or perforation;
  • patients with a history of colorectal surgery;
  • Patients with a previous history of allergy to pre-used spasmolysis;
  • Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
  • High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Related Publications (1)

  • Yao L, Li X, Wu Z, Wang J, Luo C, Chen B, Luo R, Zhang L, Zhang C, Tan X, Lu Z, Zhu C, Huang Y, Tan T, Liu Z, Li Y, Li S, Yu H. Effect of artificial intelligence on novice-performed colonoscopy: a multicenter randomized controlled tandem study. Gastrointest Endosc. 2024 Jan;99(1):91-99.e9. doi: 10.1016/j.gie.2023.07.044. Epub 2023 Aug 1.

    PMID: 37536635DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Yu Honggang, Doctor

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Double (Participant, Investigator)
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

April 12, 2022

Study Start

March 24, 2022

Primary Completion

October 24, 2022

Study Completion

November 24, 2022

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

CN(1)