Viewing Study NCT02688751



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Last Modification Date: 2024-10-26 @ 11:57 AM
Study NCT ID: NCT02688751
Status: COMPLETED
Last Update Posted: 2022-06-09
First Post: 2015-12-16

Brief Title: Contrast Enhanced Ultrasound Endoleak Detection Following EVAR v13
Sponsor: Liverpool University Hospitals NHS Foundation Trust
Organization: Liverpool University Hospitals NHS Foundation Trust

Study Overview

Official Title: Contrast Enhanced Ultrasound Endoleak Detection Compared To Time-Resolved Computer Tomography Angiography in High Risk Endovascular Aneurysm Repair EVAR Surveillance Patients
Status: COMPLETED
Status Verified Date: 2016-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A single site cross-sectional comparison of paired diagnostic imaging modalities

This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks in comparison to tCTA following EVAR It will collect data to allow comparison of diagnostic accuracy across modalities including CDU CEUS and tCTA It will collect time taken to perform the various types of scan to allow healthcare costs to be calculated for each imaging modality
Detailed Description: This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks in comparison to tCTA following EVAR It will collect data to allow comparison of diagnostic accuracy across modalities including CDU CEUS and tCTA It will collect time taken to perform the various types of scan to allow healthcare costs to be calculated for each imaging modality

Collected data will be analysed regarding two novel hypothesised methods of using CEUS information

The first is recording temporal delay between contrast in graft and contrast in endoleak to define endoleak type Potentially this could be used as a faster method of defining endoleak type in a surveillance programme

The second is to identifyrefute correlation between CEUS contrast to appear in endoleak vs tCTA contrast to appear in endoleak If an association can be established CEUS timings could potentially then be used to time standard CTA phases to improve CTAs diagnostic accuracy

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
15NW0908 OTHER NHS REC None