Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

March 7, 2016 updated by: InSightec

Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer

Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Sheba medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simulated ExAblate MRgFUS
Patients undergoing simulated ExAblate MRgFUS device use
Device: ExAblate MRgFUS for prostate cancer
Simulated use of ExAblate MRgFUS system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device-related adverse events
Time Frame: Throughout study period
Throughout study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Device compatibility with human anatomy
Time Frame: During simulated device use
During simulated device use
MR Imaging Quality
Time Frame: During simulated device use
During simulated device use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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