Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
NCT ID: NCT00811265
Last Updated: 2016-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2009-01-31
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
NCT01226576
Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions
NCT01657942
Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions
NCT03998657
Focal ExAblate MR-Guided Focused Ultrasound Treatment for Management of Organ-Confined Intermediate Risk Prostate Cancer
NCT02968784
MR-guided Focused Ultrasound Treatment of Prostate Cancer: Focal Therapy for Locally Non-Advanced Disease
NCT01522118
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Simulated ExAblate MRgFUS
Patients undergoing simulated ExAblate MRgFUS device use
ExAblate MRgFUS for prostate cancer
Simulated use of ExAblate MRgFUS system
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ExAblate MRgFUS for prostate cancer
Simulated use of ExAblate MRgFUS system
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
InSightec
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sheba Medical Center
Tel Litwinsky, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Web page of clinical study Sponsor
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PC001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.