A Study of Optical Fusion Trans-Perineal Grid

NCT ID: NCT05573048

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-04

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Trans-Perineal Grid for prostate interventions

Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure.

Group Type EXPERIMENTAL

Trans-Perineal Grid

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clear Guide Medical Inc.

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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David A. Woodrum

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Woodrum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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22-003369

Identifier Type: -

Identifier Source: org_study_id

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