NCT02717481

Brief Summary

Examine a new method based on fusion between ultrasound (US) and previous ultrasound/computerized tomography(US/CT) studies to evaluate the size of abdominal aneurysm and measure the changes over time and following invasive repair procedure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

March 13, 2016

Last Update Submit

March 17, 2016

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (1)

  • Exact and reliable evaluation of the aneurysm size

    The size of the aneurysm will be evaluated by two different doctors or twice with large time frame between the studies. The difference between the measurements with the fusion technology will be compared to the difference without the fusion technology. The accuracy of the measurement will be evaluated by comparing to previous CT examination.

    two years

Secondary Outcomes (3)

  • The size difference between systolic and diastolic aneurysm.

    two years

  • Aneurysm neck size and changes following an invasive procedure to repair it (EVAR).

    two years

  • Evaluation of the pressure on the aneurysmal wall.

    two years

Study Arms (1)

Patients with known aortic aneurysm

Patients with known abdominal aortic aneurysm diagnosed in clinical follow-up or after an invasive procedure to repair it. US-CT Fusion examination

Device: US-CT Fusion examination

Interventions

US-CT Fusion examinationDEVICE

Patients will undergo an US examination using an US device with US-CT Fusion capabilities.

Patients with known aortic aneurysm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it

You may qualify if:

  • Patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it.

You may not qualify if:

  • Inability to perform Ultrasound
  • Pace maker
  • Hemodynamic instability
  • Inability to cooperate in US examination
  • Pregnant Women - does not undergo CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam healt care campus, Department of Medical Imaging

Haifa, 3109601, Israel

Location

Related Publications (3)

  • Kobeiter H, Nahum J, Becquemin JP. Zero-contrast thoracic endovascular aortic repair using image fusion. Circulation. 2011 Sep 13;124(11):e280-2. doi: 10.1161/CIRCULATIONAHA.110.014118. No abstract available.

    PMID: 21911788BACKGROUND

  • McNally MM, Scali ST, Feezor RJ, Neal D, Huber TS, Beck AW. Three-dimensional fusion computed tomography decreases radiation exposure, procedure time, and contrast use during fenestrated endovascular aortic repair. J Vasc Surg. 2015 Feb;61(2):309-16. doi: 10.1016/j.jvs.2014.07.097. Epub 2014 Aug 28.

    PMID: 25175634BACKGROUND

  • Pfister K, Schierling W, Jung EM, Apfelbeck H, Hennersperger C, Kasprzak PM. Standardized 2D ultrasound versus 3D/4D ultrasound and image fusion for measurement of aortic aneurysm diameter in follow-up after EVAR. Clin Hemorheol Microcirc. 2016;62(3):249-60. doi: 10.3233/CH-152012.

    PMID: 26484714BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Diana Gaitini, MD, Prof.

    Director of Ultrasound Unit, Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Gaitini, MD, Prof.

CONTACT

+972-4-7773675d_gaitini@rambam.health.gov.il

Gil Zur, MD

CONTACT

+972-52-3504502g_zur@rambam.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2016

First Posted

March 23, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

September 1, 2018

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

IL(1)