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| Name | Class |
|---|---|
| Clear Guide Medical Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans-Perineal Grid for prostate interventions | Experimental | Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-Perineal Grid | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Needle placement accuracy | Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Woodrum, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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