NCT05643612

Brief Summary

Spleen laceration is a lethal abdominal trauma and usually be diagnosed by medical images such as computed tomography. Deep learning had been proved its usage in detect abnormalities in medical images. In this trial, we used de-identified registry databank to develop a novel deep-learning based algorithm to detect the spleen trauma and to identify the injury locations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

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

Study Start

First participant enrolled

February 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
Last Updated

December 9, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

November 30, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

deep learningartificial intelligencespleen traumaspleen injury

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Diagnostic accuracy of the deep learning algorithm to detect splenic injury

    3 days

Secondary Outcomes (1)

  • Comparison of difference backbone of algorithm

    3 days

Study Arms (2)

splenic injury group

We retrospectively collected data from patients who underwent contrast-enhanced abdominal CT in the emergency department of Chang Gung Memorial Hospital, Linko, due to trauma and acute abdomen from Jul 2008 to Dec 2017. We identified 300 venous phase scans with splenic injury.

Diagnostic Test: Deep learning algorithm

control group

We retrospectively collected data from patients who underwent contrast-enhanced abdominal CT in the emergency department of Chang Gung Memorial Hospital, Linko, due to trauma and acute abdomen from Jul 2008 to Dec 2017. We randomly selected 300 additional venous phase scans without splenic injury

Diagnostic Test: Deep learning algorithm

Interventions

A sequential two-stage 3D spleen injury detection framework to identify splenic injury in the CT scans

control groupsplenic injury group

Eligibility Criteria

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

We enrolled images of the patients who underwent abdominal computed tomography in emergency department for trauma and acute abdominal survey from Jul 2008 to Dec 2017. Then we selected 300 images with splenic injury and 300 images without.

You may qualify if:

  • patients who underwent abdominal computed tomography in emergency department for trauma and acute abdominal survey from Jul 2008 to Dec 2017.

You may not qualify if:

  • poor quality images
  • no contrast series of computed tomography images.
  • images from other hospitals without proper evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung memorial hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Interventions

Detection Algorithms

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Officials

  • Chien-Hung Liao, MD.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 9, 2022

Study Start

February 1, 2022

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

December 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Because we extract the de-identified data from registry databank, we could not offer individual participant data.

Locations