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Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
The objective of this study is to evaluate safety, compatibility and imaging quality of the ExAblate MRgFUS system for prostate cancer, under simulated use conditions. No acoustic energy will be delivered and no focused ultrasound therapy will be performed. This is an imaging only study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulated ExAblate MRgFUS | Experimental | Patients undergoing simulated ExAblate MRgFUS device use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExAblate MRgFUS for prostate cancer | Device | Simulated use of ExAblate MRgFUS system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device-related adverse events | Throughout study period |
| Measure | Description | Time Frame |
|---|---|---|
| Device compatibility with human anatomy | During simulated device use | |
| MR Imaging Quality | During simulated device use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Tel Litwinsky | Israel |
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| Label | URL |
|---|---|
| Web page of clinical study Sponsor | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |