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

University of Miami

Status: Completed

Conditions: Enlarged Prostate

Treatments: Device: cone-beam CT 3D Emboguide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03164629

20160589

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 50 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

3D Angiogram + Emboguide

Experimental group

Description:

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.

Treatment:

Device: cone-beam CT 3D Emboguide

No 3D Angiogram + Emboguide

Active Comparator group

Description:

Embolization will be guided by a standard of care CT.

Treatment:

Device: cone-beam CT 3D Emboguide