NCT04503226

Brief Summary

Deep learning applied to plain abdominal radiographic surveillance after Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA).

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
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

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

Study Start

First participant enrolled

October 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

August 4, 2020

Last Update Submit

August 4, 2020

Conditions

Keywords

Endovascular Aneurysm RepairSurveillanceDevice migrationDevice disintegration

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy

    The diagnostic accuracy of deep learning based algorithm compared to trained human interpretation in the detection of stent graft migration, disintegration and distortion on plain x-rays after EVAR.

    1-10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (approximately n = 800) who have undergone EVAR at the Royal Liverpool University Hospital between 2005 and 2013.

You may qualify if:

  • Patients who have undergone EVAR at the Royal Liverpool University Hospital between 2005 and 2013.
  • Patients who were treated for standard infra-renal AAAs.
  • Patients who are on our post-operative surveillance programme and have had 5 plain abdominal radiographs to date.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liverpool

Liverpool, Merseyside, L7 8TX, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Srinivasa Rao Vallabhaneni, MD, FRCS

    Royal Liverpool University Hospital NH STrust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 7, 2020

Study Start

October 1, 2019

Primary Completion

October 15, 2020

Study Completion

December 31, 2020

Last Updated

August 7, 2020

Record last verified: 2019-08

Locations