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Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer

2014-08-27 03:45:57 | BioPortfolio

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.

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.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

Integrated Imaging High Intensity Focused Ultrasound

Location

Chinn & Chinn Urology Associates
Arcadia
California
United States
91006

Status

Active, not recruiting

Source

EDAP TMS S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:57-0400

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PubMed Articles [37590 Associated PubMed Articles listed on BioPortfolio]

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Prostate Cancer - Local Treatment after Radiorecurrence: HIFU - High-Intensity Focused Ultrasound.

High intensity focused ultrasound: The fundamentals, clinical applications and research trends.

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Medical and Biotech [MESH] Definitions

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

The use of focused, high-frequency sound waves to destroy tissue. It is sometimes used in conjunction with but is distinct from INTERVENTIONAL ULTRASONOGRAPHY.

The use of HIGH-ENERGY SHOCK WAVES, in the frequency range of 20-60 kHz, to cut through or remove tissue. The tissue fragmentation by ultrasonic surgical instruments is caused by mechanical effects not heat as with HIGH-INTENSITY FOCUSED ULTRASOUND ABLATION.

The application of high intensity ultrasound to liquids.

A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.

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