Clinical Trial TitleA Pilot Study in Human Subjects Evaluating the Use of the NanoKnife System for Ablation of Prostate Cancer Tissue in a Low and Intermediate Risk Patient Population
National Clinical Trial Number:NCT01972867
Clinical Trial Protocol Description:
This study was initiated to evaluate the short-term safety, as well as the feasibility, of using the NanoKnife System as a focal therapy option for prostate cancer treatment.
The NanoKnife System is an ablation device used to destroy a targeted area of tissue. The device uses Irreversible Electroporation or IRE, which is a technique in which electrical pulses are applied to targeted cells. The pulses create small holes in the cell membranes as they pass through. After enough pulses are delivered to the cells, the cells die. The NanoKnife System uses probes that are placed around a targeted area of tissue to deliver electrical pulses. The probes are plugged into a generator that delivers and
monitors the procedure.
Currently, the NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have at least a 10 year life expectancy.
- Have histologically confirmed organ-confined prostate cancer (Clinical Stage T1 or T2a).
- Have a PSA less than 10 ng/mL.
- Have a Gleason score of 3+3 or 3+4/4+3.
You will be excluded from the study if any of the following criteria apply to you:
- Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium.
- Are unfit for anthesthia or have a contraindication for agents listed for paralysis.
- Have an active urinary tract infection (UTI).
- Have a history of bladder neck contracture.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.