Trials / Unknown
UnknownNCT00295802
Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- EDAP TMS S.A. · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Integrated Imaging High Intensity Focused Ultrasound | |
| DEVICE | Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy) | Cryotherapy |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2012-08-01
- Completion
- 2014-09-01
- First posted
- 2006-02-24
- Last updated
- 2014-02-07
Locations
15 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00295802. Inclusion in this directory is not an endorsement.