Automatic Abdominal Aortic Aneurysm Diameter Measurement

August 30, 2023 updated by: Natasha Monzon Svendsen

Automated Three-dimensional Ultrasound Bridges the Gap Between Novices and Experts in Diameter Assessment of Abdominal Aortic Aneurysms

Managing abdominal aortic aneurysms currently relies on diameter assessment with ultrasound. Diameter reproducibility with two-dimensional ultrasound is challenging, and requires experienced operators. A novel automatic three-dimensional ultrasound system has the potential to facilitate more precise diameter measurements than two-dimensional ultrasound. This study aimed to assess the variance of abdominal aortic aneurysm diameter measurements among ultrasound novices and experts by comparing two-dimensional ultrasound with the three-dimensional ultrasound system in a clinical setting.

Ten patients under abdominal aortic aneurysm surveillance were examined by 29 ultrasound-operators: 13 experts and 16 novices. The experts were sonographers and physicians highly experienced in abdominal aortic aneurysm ultrasound, and the novices were medical students and junior residents with sparse ultrasound experience.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2300
        • Department of Vascular Surgery, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The ten patients were selected from a large vascular surgery outpatient clinic.

Description

Inclusion Criteria:

-Patients with an abdominal aortic aneurysm > 3 cm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
All ten patients had their abdominal aortic aneurysm measured by experts and novices using both two-dimensional and three-dimensional ultrasound
Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA

All patients had their abdominal aortic aneurysm maximum anterior-posterior diameter estimated with two-dimensional ultrasound using a 5 MHz curved array transducer (Philips® C5-1 transducer, Philips Healthcare, Bothell, WA, USA).

After the acquisition, a three-dimensional ultrasound acquisition was performed with a 3D-matrix transducer (Philips® X6-1 transducers, Philips Healthcare, Bothell, WA, USA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal aortic aneurysm measurement variance between novices and experts
Time Frame: One week
The primary outcome was to test the variance of abdominal aortic aneurysm diameter measurements by comparing expert and novice ultrasound operators using conventional 2D-ultrasound and 3D-software assisted ultrasound.
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natasha Monzon Svendsen

Collaborators

Philips Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2022

Primary Completion (Actual)

February 14, 2022

Study Completion (Actual)

February 14, 2022

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20001116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on AAA - Abdominal Aortic Aneurysm

Clinical Trials on Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe