A Study of Optical Fusion Trans-Perineal Grid

January 13, 2026 updated by: David A. Woodrum, Mayo Clinic

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trans-Perineal Grid for prostate interventions
Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure.
Device: Trans-Perineal Grid
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needle placement accuracy
Time Frame: Baseline
Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Clear Guide Medical Inc.

Investigators

  • Principal Investigator: David Woodrum, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2022

Primary Completion (Actual)

December 30, 2023

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-003369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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