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Enrolling by invitation NCT05573048

A Study of Optical Fusion Trans-Perineal Grid

No phase Interventional Prostate Biopsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trans-Perineal Grid.
Who it may be relevant to
Registry conditions: Prostate Biopsy. Basic parameters: from 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Optical Fusion Trans-Perineal Grid

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.

Interventions

  • 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.

Primary outcome measures

  • Needle placement accuracy [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Mayo Clinic Minnesota — Rochester

Identifiers

NCT: NCT05573048 · 22-003369

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗