A Study of Optical Fusion Trans-Perineal Grid

N/AEnrolling By InvitationNCT05573048

Mayo Clinic20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Prostate Biopsy

Interventions

Trans-Perineal GridDEVICE

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.

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Needle placement accuracy

Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and

Time frame: Baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.