NCT06481358

Brief Summary

The study will compare the diagnostic accuracy and time to diagnosis of computed tomography images of patients with suspected intestinal obstruction seen in the emergency room by residents and surgeons, with and without artificial intelligence.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 25, 2024

Last Update Submit

June 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The diagnosis of the obstruction site

    Accuracy of diagnosis of the obstruction site

    September, 2024

Study Arms (2)

AI group

Participants read CT images with AI.

Diagnostic Test: Artificial intelligence

Manual group

Participants read CT images without AI

Interventions

AI extract intestinal region and reconstruct into 3D image.

AI group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

20 people

You may qualify if:

  • Persons with documented consent

You may not qualify if:

  • Persons without documented consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagoya University Graduate School of Medicine

Nagoya, Aichi-ken, 4668560, Japan

Location

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Officials

  • Hieoo Uchida, PhD.

    Nagoya University Graduate School of Medicine, Pediatric Surgery

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Staff

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 1, 2024

Study Start

September 1, 2022

Primary Completion

June 6, 2023

Study Completion

October 31, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations