Automatic Abdominal Aortic Aneurysm Diameter Measurement

NCT ID: NCT05983016

Last Updated: 2023-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-15

Study Completion Date

2022-02-14

Brief Summary

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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.

Detailed Description

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Conditions

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AAA - Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

All ten patients had their abdominal aortic aneurysm measured by experts and novices using both two-dimensional and three-dimensional ultrasound

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

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

-Patients with an abdominal aortic aneurysm \> 3 cm.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role collaborator

Natasha Monzon Svendsen

OTHER

Sponsor Role lead

Responsible Party

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Natasha Monzon Svendsen

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Vascular Surgery, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-20001116

Identifier Type: -

Identifier Source: org_study_id

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