Automatic Abdominal Aortic Aneurysm Diameter Measurement

AAA - Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05983016
• Other study ID #: H-20001116
• Status: Completed
• Start date: January 15, 2022
• Est. completion date: February 14, 2022

Study information

• Verified date: August 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 14, 2022
• Est. primary completion date: February 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-Patients with an abdominal aortic aneurysm > 3 cm.

Related Conditions & MeSH terms

• AAA - Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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).

Locations

Country	Name	City	State
Denmark	Department of Vascular Surgery, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Natasha Monzon Svendsen	Philips Healthcare

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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