NCT04275609

Brief Summary

The purpose of this study is to compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

29 days

First QC Date

February 14, 2020

Last Update Submit

February 18, 2020

Conditions

Keywords

Endoscopic ReportArtificial IntelligenceGastrointestinal DiseaseWriting Efficiency

Outcome Measures

Primary Outcomes (1)

  • The time spent writing reports

    Sum of the time for writing gastroscopic report and colonoscopic report。

    Intraoperative

Study Arms (2)

Artificial Intelligence generating endoscopic report

EXPERIMENTAL

In this group, the endoscopic report was generated by artificial intelligence (AI) based on the structured diagnostic report generation system.

Other: AI generated report

Physicians writing endoscopic report

ACTIVE COMPARATOR

In this group, the endoscopic report was writing by physicians.

Other: physicians writing report

Interventions

After the endoscopic procedure, the physicians click the structured reporting button of computer to automatically complete the report through the structured diagnostic report generation system. The physicians only make minor corrections to the report.

Artificial Intelligence generating endoscopic report

After the endoscopic procedure, the physicians writing the report in computer according the procedure.

Physicians writing endoscopic report

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged between 18 and 80 years;
  • patients undergoing gastroscopy and colonoscopy examination with anesthesia;
  • patients able to give informed consent

You may not qualify if:

  • patients with the contraindications to endoscopic examination;
  • a history of gastrointestinal cancers;
  • allergic to anaesthetics in previous medical history;
  • the endoscopic procedure cannot be completed due to stenosis, obstruction, solid food or complications of anaesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Xiuli Zuo, MD,PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Qilu Hospital gastroenterology department

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 19, 2020

Study Start

February 20, 2020

Primary Completion

March 20, 2020

Study Completion

March 30, 2020

Last Updated

February 19, 2020

Record last verified: 2020-02