Automatic Abdominal Aortic Aneurysm Diameter Measurement

NCT05983016 | Completed FDA Device

• 1 other identifier: H-20001116
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AAA - Abdominal Aortic Aneurysm

Keywords

Ultrasound; Three dimensional ultrasound; Abdominal aortic aneurysm; Sonography; 3D ultrasound

Outcome Measures

Primary Outcomes (1)

• Abdominal aortic aneurysm measurement variance between novices and experts

  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

Study Arms (1)

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

Interventions

Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA DEVICE

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).

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with an abdominal aortic aneurysm \> 3 cm.

Sponsors & Collaborators

• Natasha Monzon Svendsen: lead
• Philips Healthcare: collaborator

Study Sites (1)

Department of Vascular Surgery, Rigshospitalet

Copenhagen, 2300, Denmark

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: January 15, 2022
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

DK (1)