Enlarged Prostate
Conditions
Keywords
BPH, Lower Urinary Track Infection, Urine Retention
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.
Interventions
DEVICEcone-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.
Sponsors
Siemens Corporation, Corporate Technology
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for Prostatic Artery Catheterization | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3D Angiogram + Emboguide 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. | 25 |
| No 3D Angiogram + Emboguide Embolization will be guided by a standard of care CT. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | 3D Angiogram + Emboguide | No 3D Angiogram + Emboguide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 13 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 12 Participants | 26 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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.
Time frame: hour 2
Population: at times unable to catheterize the participants arteries
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3D Angiogram + Emboguide | Time for Prostatic Artery Catheterization | Right Artery | 273.40 seconds | Standard Deviation 406.64 |
| 3D Angiogram + Emboguide | Time for Prostatic Artery Catheterization | Left Artery | 206.38 seconds | Standard Deviation 228.96 |
| No 3D Angiogram + Emboguide | Time for Prostatic Artery Catheterization | Right Artery | 181.71 seconds | Standard Deviation 185.11 |
| No 3D Angiogram + Emboguide | Time for Prostatic Artery Catheterization | Left Artery | 155.96 seconds | Standard Deviation 216.32 |