Prostate Biopsy
Conditions
Keywords
Prostate Ablation Procedure
Brief summary
The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.
Interventions
DEVICETrans-Perineal Grid
A small square piece of plastic with many holes in it placed between the legs to help guide the path of the interventional instruments and to facilitate the prostate intervention. The guide grid will help with needle placement using the grid technology.
Sponsors
Clear Guide Medical Inc.
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for a MR guided biopsy or ablation. * One, two, or three tumor suspicious regions identified on multiparametric MRI. * Tolerance for anesthesia/sedation. * Ability to give informed consent.
Exclusion criteria
* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. * History of other primary non-skin malignancy within previous three years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needle placement accuracy | Baseline | Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and |
Countries
United States
Outcome results
None listed