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| Sponsored by: |
EDAP TMS S.A. |
| Information provided by: | EDAP TMS S.A. |
| ClinicalTrials.gov Identifier: | NCT00295802 |
Purpose
The purpose of this study is to determine the substantial equivalence of the Ablatherm high intensity focused ultrasound (HIFU) as compared to cryotherapy for the treatment of low risk, localized prostate cancer.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Device: Integrated Imaging High Intensity Focused Ultrasound |
Phase II Phase III |
| MedlinePlus related topics: | Cancer Prostate Cancer Ultrasound |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer |
| Estimated Enrollment: | 446 |
| Study Start Date: | April 2006 |
| Arms | Assigned Interventions |
|
1: Experimental
HIFU
|
Device: Integrated Imaging High Intensity Focused Ultrasound |
|
2: Experimental
Cryo
|
Device: Integrated Imaging High Intensity Focused Ultrasound |
Primary hypothesis of this clinical investigation is that HIFU with the Ablatherm Integrated Imaging is non-inferior to minimally invasive cryosurgery as an effective treatment method for low risk, localized prostate cancer.
Eligibility
| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Call Center | 866-650-4466 |
| United States, California | |||||
| Chinn & Chinn Urology Associates | Recruiting | ||||
| Arcadia, California, United States, 91006 | |||||
| Principal Investigator: Douglas Chinn, MD | |||||
| United States, Colorado | |||||
| Univeristy of Colorado Hospital and Health Science Center | Recruiting | ||||
| Aurora, Colorado, United States, 80010 | |||||
| Principal Investigator: E. David Crawford, MD | |||||
| Sub-Investigator: James Lugg, MD | |||||
| Sub-Investigator: Paul Maroni, MD | |||||
| United States, Florida | |||||
| Florida Foundation for Healthcare Research Inc | Recruiting | ||||
| Ocala, Florida, United States, 34474 | |||||
| Principal Investigator: Russell Locke, MD | |||||
| Sub-Investigator: Ira Klimberg, MD | |||||
| Sub-Investigator: Rick Sessions, PA-C | |||||
| Sub-Investigator: Roger Madore, PA-C | |||||
| Sub-Investigator: William Smith, PA-C | |||||
| Atlantic Urology Associates | Recruiting | ||||
| Daytona Beach, Florida, United States | |||||
| Principal Investigator: Martin Dineen, MD | |||||
| United States, New Jersey | |||||
| Hackensack University Medical Center | Recruiting | ||||
| Hackensack, New Jersey, United States, 07601 | |||||
| Principal Investigator: Ihor Sawczuk, MD | |||||
| Sub-Investigator: Ravi Munver, MD | |||||
| United States, New York | |||||
| Sloan-Kettering Institute | Recruiting | ||||
| New York, New York, United States | |||||
| Principal Investigator: James Eastham, MD | |||||
| United States, North Carolina | |||||
| Duke University Medical Center | Recruiting | ||||
| Durham, North Carolina, United States, 27710 | |||||
| Principal Investigator: Cary Robertson, MD | |||||
| United States, Ohio | |||||
| Cleveland Clinic Foundation | Recruiting | ||||
| Cleveland, Ohio, United States, 44195 | |||||
| Principal Investigator: Stephen Jones, M.D. | |||||
| United States, Pennsylvania | |||||
| Thomas Jefferson University | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19107 | |||||
| Principal Investigator: Edouard Trabulsi, M.D. | |||||
| Sub-Investigator: Leonard Gomella, M.D. | |||||
| Geisinger Medical Center | Recruiting | ||||
| Danville, Pennsylvania, United States | |||||
| Principal Investigator: Dan Rukstalis, MD | |||||
| United States, Tennessee | |||||
| Vanderbilt University Medical Center | Recruiting | ||||
| Nashville, Tennessee, United States, 37232-2765 | |||||
| Principal Investigator: Sam Chang, MD | |||||
| Sub-Investigator: Michael Cookson, MD | |||||
| United States, Texas | |||||
| Urolgoy Associates of North Texas | Recruiting | ||||
| Arlington, Texas, United States, 76017 | |||||
| Principal Investigator: H. Patterson Hezmall, MD | |||||
| Scott & White Hospital | Recruiting | ||||
| Temple, Texas, United States, 76508 | |||||
| Principal Investigator: Belur Patel, MD | |||||
| The University of Texas M.D. Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States, 77230 | |||||
| Principal Investigator: John F Ward, MD | |||||
| United States, Virginia | |||||
| Virginia Urology Center | Recruiting | ||||
| Richmond, Virginia, United States, 23235 | |||||
| Principal Investigator: Anthony Sliwinski, MD | |||||
| Sub-Investigator: Charles Wadsworth, MD | |||||
| Canada, Ontario | |||||
| Maple Leaf HIFU | Recruiting | ||||
| Hamilton, Ontario, Canada, L&N 4A6 | |||||
| Principal Investigator: William Orovan, MD | |||||
| EDAP TMS S.A. |
| Principal Investigator: | Carey Robertson, MD | Duke University |
More Information
| Responsible Party: | EDAP Technomed ( John Rewcastle ) |
| Study ID Numbers: | G050103 |
| First Received: | February 22, 2006 |
| Last Updated: | July 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00295802 |
| Health Authority: | United States: Food and Drug Administration |
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