NCT05858827

Brief Summary

In this study, the EUS intelligent picture reporting system can automatically generate reports after reading videos of EUS examinations. This function can standardize the quality of endoscopic ultrasound image reporting and reduce the work burden of ultrasound endoscopists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

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

May 5, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

May 5, 2023

Last Update Submit

January 10, 2024

Conditions

Endoscopic UltrasonographyArtificial Intelligence

Keywords

Endoscopic UltrasonographyArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • completeness of capturing standard stations

    The number of standard stations correctly captured by EUS-AIRS is divided by the number of all standard stations in the endoscopic ultrasound procedures

    2 months

Secondary Outcomes (3)

  • accuracy of capturing standard stations

    2 months

  • completeness of capturing detected lesions

    2 months

  • completeness of capturing biopsy procedures

    2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population was patients undergoing endoscopic ultrasonography who met all inclusion criteria and did not meet all exclusion criteria.

You may qualify if:

  • patients aged 18 years or older;
  • patients with indications for endoscopic ultrasonography of the biliary pancreatic system and undergoing sedated EUS procedures;
  • ability to read, understand, and sign informed consent;

You may not qualify if:

  • patients with absolute contraindications to EUS examination;
  • history of previous gastric surgery;
  • pregnancy;
  • severe medical illness;
  • previous medical history of allergic reaction to anesthetics;
  • stricture or obstruction of the esophagus;
  • anatomical abnormalities of the upper gastrointestinal tract due to advanced neoplasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, Wuhan, China

Location

Study Officials

  • Honggang Yu, Doctor

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 15, 2023

Study Start

May 10, 2023

Primary Completion

October 23, 2023

Study Completion

December 20, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

CN(1)