NCT05573048

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2022Dec 2026

Study Start

First participant enrolled

October 4, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

October 6, 2022

Last Update Submit

January 13, 2026

Conditions

Prostate Biopsy

Keywords

Prostate Ablation Procedure

Outcome Measures

Primary Outcomes (1)

  • Needle placement accuracy

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

    Baseline

Study Arms (1)

Trans-Perineal Grid for prostate interventions

EXPERIMENTAL

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

Device: Trans-Perineal Grid

Interventions

Trans-Perineal GridDEVICE

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.

Trans-Perineal Grid for prostate interventions

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
  • History of other primary non-skin malignancy within previous three years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • David Woodrum, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 10, 2022

Study Start

October 4, 2022

Primary Completion

December 30, 2023

Study Completion (Estimated)

December 1, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)