Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
NCT00295802 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 141
Last updated 2014-02-07
Summary
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.
Conditions
Interventions
- DEVICE
-
Integrated Imaging High Intensity Focused Ultrasound
- DEVICE
-
Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
Cryotherapy
Sponsors & Collaborators
-
EDAP TMS S.A.
lead INDUSTRY
Principal Investigators
-
Carey Robertson, MD · Duke University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2012-08-31
- Completion
- 2014-09-30
Countries
- United States
- Canada
Study Locations
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