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


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Verified May 2017 by University of Miami

Sponsor:

Collaborator:

Siemens Corporation, Corporate Technology

Information provided by (Responsible Party):

Shivank Bhatia, University of Miami

ClinicalTrials.gov Identifier:

NCT03164629

First received: May 22, 2017

Last updated: May 22, 2017

Last verified: May 2017

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.

Enlarged Prostate Device: cone-beam CT 3D Emboguide

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: 3D ROTATIONAL CT ANGIOGRAM WITH EMBOLIZATION GUIDANCE AND CBCT IN PROSTATE ARTERY EMBOLIZATION

Primary Outcome Measures:

  • Time for prostatic artery catheterization [ Time Frame: 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.

Estimated Enrollment: 50
Actual Study Start Date: April 17, 2017
Estimated Study Completion Date: October 18, 2018
Estimated Primary Completion Date: June 18, 2018 (Final data collection date for primary outcome measure)
Experimental: Study Group

The following parameters will be recorded for the study group:

  • Time for catheterization
  • Time for planning dataset for each side
  • Total dose area product
  • Dose for planning dataset for each side
  • Dose area product only for fluoroscopy
  • Total procedural time: from access to closure
  • Amount of contrast medium used
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.

Active Comparator: Control Group

The following parameters will be recorded for the control group:

  • Time for catheterization
  • Total dose area product
  • Dose area product only for fluoroscopy
  • Total procedural time: from access to closure.
  • Amount of contrast medium used
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.

Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03164629

Professional Arts Center
Miami, Florida, United States, 33136
Contact: Lia Quezada    305-243-2210    Lquezada@med.miami.edu   
Contact: Katuska Barbery    305-243-2078    kbarbery@med.miami.edu   
Principal Investigator: Shivank Bhatia, MD         

University of Miami

Siemens Corporation, Corporate Technology

Principal Investigator: Shivank Bhatia University of Miami

Responsible Party: Shivank Bhatia, Assistant Professor of Clinical Radiology & Urology, University of Miami
ClinicalTrials.gov Identifier: NCT03164629     History of Changes
Other Study ID Numbers: 20160589
Study First Received: May 22, 2017
Last Updated: May 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Miami:

BPH
Lower Urinary Track Infection
Urine Retention

ClinicalTrials.gov processed this record on May 23, 2017