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Sponsored by: |
InSightec |
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Information provided by: | InSightec |
ClinicalTrials.gov Identifier: | NCT00811265 |
Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
Condition | Intervention | Phase |
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Prostate Cancer |
Device: ExAblate MRgFUS for prostate cancer |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer |
Estimated Enrollment: | 10 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Simulated ExAblate MRgFUS: Experimental
Patients undergoing simulated ExAblate MRgFUS device use
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Device: ExAblate MRgFUS for prostate cancer
Simulated use of ExAblate MRgFUS system
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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.
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | InSightec ( Nadir Alikacem ) |
Study ID Numbers: | PC001 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00811265 |
Health Authority: | Israel: Ethics Commission |
ExAblate MRgFUS Focused ultrasound Magnetic resonance imaging Prostate cancer Radical prostatectomy candidate |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |