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

Study Overview
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Brief Summary
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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.

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

Conditions
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Enlarged Prostate

Intervention / Treatment
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* Device: cone-beam CT 3D Emboguide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D Angiogram + Emboguide<br>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<br>* 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.<br>|
| Active Comparator: No 3D Angiogram + Emboguide<br>Embolization will be guided by a standard of care CT. | Device: cone-beam CT 3D Emboguide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Lower Urinary Track Infection, Urine Retention