A Study of Optical Fusion Trans-Perineal Grid
Not Applicable
- Conditions
- Prostate Biopsy
- Interventions
- Device: Trans-Perineal Grid
- Registration Number
- NCT05573048
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Male
- Target Recruitment
- 20
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trans-Perineal Grid for prostate interventions Trans-Perineal Grid Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure.
- Primary Outcome Measures
Name Time Method Needle placement accuracy Baseline Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States