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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00295802 on ClinicalTrials.gov