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OpenTrials
Completed

NCT Number: NCT03164629

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

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.

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Key information

Conditions

Enlarged Prostate Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

50 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Professional Arts Center

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Siemens Corporation, Corporate Technology

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 23, 2017
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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