A Study of Optical Fusion Trans-Perineal Grid

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05573048
Status
Enrolling By Invitation

Conditions

  • Prostate Biopsy

Eligibility Criteria

Sex
MALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 4, 2022
Status verified
Jan 2026
Primary completion
Dec 30, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Trans-Perineal Grid for prostate interventions
    Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure.

Primary Outcome Measure

Needle placement accuracy [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905-

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By research site
Mayo Clinic Minnesota· Rochester, MN

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