AAA - Abdominal Aortic AneurysmNCT05983016
Automatic Abdominal Aortic Aneurysm Diameter Measurement
An observational study of AAA - Abdominal Aortic Aneurysm, run by Natasha Monzon Svendsen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- AAA - Abdominal Aortic Aneurysm
- What is being tested?
- Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2022to 14 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The ten patients were selected from a large vascular surgery outpatient clinic.
Who may be able to join
- -Patients with an abdominal aortic aneurysm > 3 cm.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Being tested
- Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA
- Keywords
- Ultrasound, Three dimensional ultrasound, Abdominal aortic aneurysm, Sonography, 3D ultrasound
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips EPIQ-7, Philips Healthcare, Bothell, WA, USADevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients | All ten patients had their abdominal aortic aneurysm measured by experts and novices using both two-dimensional and three-dimensional ultrasound Receives: Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start15 Jan 2022
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AAA - Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natasha Monzon Svendsen
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor-investigator, Natasha Monzon Svendsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983016
- Sponsor's protocol ID
- H-20001116
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Three-dimensional Ultrasound Bridges the Gap Between Novices and Experts in Diameter Assessment of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT05983016
- Acronym / sponsor ID
- H-20001116
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Keywords
- Ultrasound, Three dimensional ultrasound, Abdominal aortic aneurysm, Sonography, 3D ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Natasha Monzon SvendsenUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USAAll ten patients had their abdominal aortic aneurysm measured by experts and novices using both two-dimensional and three-dimensional ultrasound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The ten patients were selected from a large vascular surgery outpatient clinic.
Key inclusion criteria (1 listed)
- -Patients with an abdominal aortic aneurysm > 3 cm.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips EPIQ-7, Philips Healthcare, Bothell, WA, USAAll 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). | Device | Patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AAA - Abdominal Aortic Aneurysm, run by Natasha Monzon Svendsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal aortic aneurysm measurement variance between novices and experts (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.