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Sponsored by: |
USHIFU, LLC |
---|---|
Information provided by: | USHIFU, LLC |
ClinicalTrials.gov Identifier: | NCT00573586 |
This is an investigational study on the use of high intensity focused ultrasound (HIFU) in the management of localized prostate cancer (T1c/T2a) as a primary non-comparative study.
High intensity focused ultrasound (HIFU) is a non-invasive acoustic ablation technique that uses intersecting, precision focused ultrasound waves to raise the temperature of the target to) 80-90 degrees C in 2-3 seconds, destroying the targeted tissues (prostate cancer). The tissue targeting is highly precise, minimizing collateral damage.
The overall hypothesis is that HIFU with Sonablate can safely, effectively and selectively ablate prostate cancer tissue, resulting in complete tissue necrosis, in patients diagnosed with localized T1c/T2a prostate cancer, with minimal morbidity.
The specific hypothesis is that the Sonablate has the ability to:
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Device: Sonablate 500 (SB-500) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Investigational Study For the Treatment of Localized (T1c/T2a) Prostate Cancer With High Intensity Focused Ultrasound (HIFU) Using the Sonablate® 500 (SB-500) System in Canada |
Estimated Enrollment: | 20 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2009 |
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: George Vrabec, MD | gvrabec@hotmail.com |
Canada, British Columbia | |
Abbotsford Regional Hospital Cancer Center | |
Abbotsford, British Columbia, Canada |
Principal Investigator: | George Vrabec, MD | Abbotsford Regional Hospital Cancer Center |
Responsible Party: | Principle Investigator ( George Vrabec, MD ) |
Study ID Numbers: | USHIFU-CABC-PC002 |
Study First Received: | December 12, 2007 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00573586 History of Changes |
Health Authority: | Canada: Health Canada |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |