Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01790451 | Safety and Efficacy of Irreversible Electroporation in Ablation of Prostate Cancer in Humans | PHASE1 | COMPLETED | 16 | — | — | Aug 1, 2013 | Oct 1, 2014 | Feb 20, 2015 | 1 | Netherlands |
To determine if the IRE ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.
To determine if complete ablation of the specified targeted ablation zone is achieved as measured by histopathology assessment.
| Arm | Type | Description |
|---|---|---|
| peripheral ablation | ACTIVE_COMPARATOR | an ablation of the peripheral area of the prostate |
| More central ablation | ACTIVE_COMPARATOR | an ablation, more centrally, in proximity of the urethra |
| Name | Type | Description |
|---|---|---|
| Irreversible Electroporation | PROCEDURE | - |
Inclusion Criteria: 1. Patients with prostate cancer who are indicated to undergo a radical prostatectomy 2. Life expectancy of \> 10 years 3. Able to visualize prostate gland adequately on transrectal US imaging during enrolment evaluation 4. No prostate calcification greater than 5 mm 5. Ability ...