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| Name | Class |
|---|---|
| Siemens Corporation, Corporate Technology | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No 3D Angiogram + Emboguide | Active Comparator | Embolization will be guided by a standard of care CT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shivank Bhatia | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Professional Arts Center | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3D Angiogram + Emboguide | The following parameters will be recorded for the study group: 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. |
| FG001 | No 3D Angiogram + Emboguide | Embolization will be guided by a standard of care CT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | at times unable to catheterize the participants arteries | Posted | Mean | Standard Deviation | seconds | hour 2 |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3D Angiogram + Emboguide | articipants 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shivank Bhatia, MD | University of Miami | 305-585-7500 | SBhatia1@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2018 | Apr 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| No 3D Angiogram + Emboguide |
Embolization will be guided by a standard of care CT. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | No 3D Angiogram + Emboguide | Embolization will be guided by a standard of care CT. |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | No 3D Angiogram + Emboguide | Embolization will be guided by a standard of care CT. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |