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NCT03164629

3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization

Completed NA Results posted Last updated 11 June 2019
What this trial tests

NA trial testing cone-beam CT 3D Emboguide in Enlarged Prostate in 50 participants. Completed in 19 October 2018.

Timeline
17 April 2017
Primary endpoint
19 October 2018
19 October 2018

Quick facts

Lead sponsorUniversity of Miami
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment50
Start date17 April 2017
Primary completion19 October 2018
Estimated completion19 October 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Miami

Who can join

Adults 50 to 79, male only, with Enlarged Prostate. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time for Prostatic Artery Catheterization Primary · hour 2

For the cases using Emboguide this will be measured as the time from which the Emboguide is displayed on the live fluoroscopy to the time of prostatic artery catheterization. Emboguide display is in addition to the angiogram roadmap display. For the control cases this will be measured as the time from which the angiogram is displayed on the live fluoroscopy to the time of prostatic artery catheterization.

Right Artery
GroupValue95% CI
3D Angiogram + Emboguide273.40± 406.64
No 3D Angiogram + Emboguide181.71± 185.11
Left Artery
GroupValue95% CI
3D Angiogram + Emboguide206.38± 228.96
No 3D Angiogram + Emboguide155.96± 216.32

Sponsor's own description

The purpose of this research study is to learn about how cone-beam Computerized Tomography scans (X-ray images taken from different angles) work together with an embolization guidance software (helps the doctor see the arteries that feed the prostate)to find and see arteries in the prostate.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other University of Miami trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03164629.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing