A Study of Optical Fusion Trans-Perineal Grid

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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Key information

Conditions

Prostate Biopsy

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

Needle placement accuracy

Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

Clear Guide Medical Inc.

Registry information

Official study title

Optical Fusion Trans-Perineal Grid

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2026
First posted: Oct 10, 2022
Registry last updated: Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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