Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer
1 other identifier
interventional
10
1 country
1
Brief Summary
Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 prostate-cancer
Started Jan 2009
Typical duration for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedMarch 8, 2016
March 1, 2016
4.4 years
December 17, 2008
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Device-related adverse events
Throughout study period
Secondary Outcomes (2)
Device compatibility with human anatomy
During simulated device use
MR Imaging Quality
During simulated device use
Study Arms (1)
Simulated ExAblate MRgFUS
EXPERIMENTALPatients undergoing simulated ExAblate MRgFUS device use
Interventions
Simulated use of ExAblate MRgFUS system
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InSighteclead
Study Sites (1)
Sheba Medical Center
Tel Litwinsky, Israel
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 18, 2008
Study Start
January 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
March 8, 2016
Record last verified: 2016-03