Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05983016
Other study ID # H-20001116
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05064540 - JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization N/A
Active, not recruiting NCT03431038 - Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH N/A
Recruiting NCT03320252 - Endurant CHevAr New Indication Trial: ENCHANT
Recruiting NCT06218875 - Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Not yet recruiting NCT05399706 - Sex-specific Differences in AAA Complexity
Recruiting NCT05124184 - Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access
Not yet recruiting NCT05409118 - JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization N/A
Not yet recruiting NCT03365050 - A Study of the Safety of Targeted AAA Screening
Recruiting NCT06250998 - Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence