Safety Evaluation of ExAblate MRgFUS for Prostate Cancer - Tabular View

Tracking Information
First Received Date ^ICMJE	December 17, 2008
Last Updated Date	May 4, 2009
Start Date ^ICMJE	January 2009
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 17, 2008)	Device-related adverse events [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00811265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 17, 2008)	Device compatibility with human anatomy [ Time Frame: During simulated device use ] [ Designated as safety issue: Yes ] MR Imaging Quality [ Time Frame: During simulated device use ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
Official Title ^ICMJE	Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer
Brief Summary	Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
Detailed Description	The objective of this study is to evaluate safety, compatibility and imaging quality of the ExAblate MRgFUS system for prostate cancer, under simulated use conditions. No acoustic energy will be delivered and no focused ultrasound therapy will be performed. This is an imaging only study.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Device: ExAblate MRgFUS for prostate cancer
Study Arms / Comparison Groups	Experimental: Patients undergoing simulated ExAblate MRgFUS device use
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	10
Completion Date
Estimated Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age of patients: up to 75 years. Men scheduled for radical prostatectomy due to prostate cancer. Patients who are able and willing to give consent and able to attend all study visits. Exclusion Criteria: Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) Severely abnormal coagulation (INR>1.5) Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP > 100 on medication), and patients with cardiac pacemakers Severe cerebrovascular disease (multiple CVA or CVA within 6 months) Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.) Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc…) Any spinal pathology that prohibits maintaining supine position for more then an hour Any previous radiation to the pelvis.
Gender	Male
Ages	up to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	Israel

Administrative Information
NCT ID ^ICMJE	NCT00811265
Responsible Party	Nadir Alikacem, InSightec
Study ID Numbers ^ICMJE	PC001
Study Sponsor ^ICMJE	InSightec
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	InSightec
Verification Date	May 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP