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

Not Applicable

Completed

• Conditions: Enlarged Prostate
• Interventions: Device: cone-beam CT 3D Emboguide

• Registration Number: NCT03164629
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-04-17
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Primary Completion: 2018-10-19
• Study Completion: 2018-10-19
• Results First Submitted: 2019-04-28
• Results First Submitted QC: 2019-04-28
• Results First Posted: 2019-05-21
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Patient is age 50 to 79, inclusive
• Patients undergoing Prostate artery embolization for BPH or urinary retention -Patient has signed informed consent.

Read More

Exclusion Criteria

• Patients with biopsy proven prostate cancer
• Patient weight of >300 lbs

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D Angiogram + Emboguide	cone-beam CT 3D Emboguide	Participants will receive cone-beam CT 3D Emboguide: cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.
No 3D Angiogram + Emboguide	cone-beam CT 3D Emboguide	Embolization will be guided by a standard of care CT.

Primary Outcome Measures

Name	Time	Method
Time for Prostatic Artery Catheterization	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.

Trial Locations

Locations (1)

Professional Arts Center; 🇺🇸 Miami, Florida, United States