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

Enlarged Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164629
• Other study ID #: 20160589
• Status: Completed
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: October 19, 2018

Study information

• Verified date: June 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patient is age 50 to 79, inclusive

• Patients undergoing Prostate artery embolization for BPH or urinary retention -Patient has signed informed consent.

Exclusion Criteria:

• Patients with biopsy proven prostate cancer

• Patient weight of >300 lbs

Related Conditions & MeSH terms

• Enlarged Prostate

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Professional Arts Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for Prostatic Artery Catheterization	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.	hour 2