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

NCT03164629 | Completed Results FDA Device

• 1 other identifier: 20160589
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Enlarged Prostate

Keywords

BPH; Lower Urinary Track Infection; Urine Retention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

3D Angiogram + Emboguide

EXPERIMENTAL

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.

Device: cone-beam CT 3D Emboguide

No 3D Angiogram + Emboguide

ACTIVE COMPARATOR

Embolization will be guided by a standard of care CT.

Device: cone-beam CT 3D Emboguide

Interventions

cone-beam CT 3D Emboguide DEVICE

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.

3D Angiogram + Emboguide; No 3D Angiogram + Emboguide

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Professional Arts Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Shivank Bhatia, MD
• Organization: University of Miami

SBhatia1@miami.edu

305-585-7500

Study Officials

• Shivank Bhatia

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Radiology & Urology

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: April 17, 2017
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: June 11, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)