Clinical trial · Interventional
Safety Evaluation of ExAblate MRgFUS for Prostate Cancer
Safety, Compatibility and Imaging Quality of ExAblate Prostate Applicator for Prostate Cancer
NCT00811265CI-TRIAL-00021252completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ExAblate MRgFUS for prostate cancer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Simulated ExAblate MRgFUS
- description
- Patients undergoing simulated ExAblate MRgFUS device use
- interventionNames
- Device: ExAblate MRgFUS for prostate cancer
Primary outcomes (1)
- measure
- Device-related adverse events
- timeFrame
- Throughout study period
Secondary outcomes (2)
- measure
- Device compatibility with human anatomy
- timeFrame
- During simulated device use
- measure
- MR Imaging Quality
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.