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Device

Trans-Perineal Grid Technique for Prostate Biopsy

N/A
Waitlist Available
Led By David Woodrum, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled for a MR guided biopsy or ablation.
Be older than 18 years old
Must not have
History of other primary non-skin malignancy within previous three years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new tech to help doctors find the best needle path for prostate treatment.

Who is the study for?
This trial is for individuals scheduled for an MR-guided prostate biopsy or ablation, who have 1-3 suspicious tumor regions on MRI and can consent to the study. They must tolerate anesthesia/sedation. Those with conditions not compatible with MRI or a history of non-skin cancer in the last three years cannot participate.
What is being tested?
The study is testing a new needle guide grid called Clear Guide SCENERGY - MR, which has VisiMARKER II to help automatically register and target the prostate during biopsies or ablations, aiming to improve needle placement accuracy.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort, bruising, bleeding at the needle insertion site, infection risk from biopsy procedure, and possible allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a biopsy or ablation guided by MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had cancer other than skin cancer in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Needle placement accuracy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trans-Perineal Grid for prostate interventionsExperimental Treatment1 Intervention
Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,351 Previous Clinical Trials
3,060,937 Total Patients Enrolled
Clear Guide Medical Inc.UNKNOWN
David Woodrum, MD, PhDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
116 Total Patients Enrolled

Media Library

Trans-Perineal Grid (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05573048 — N/A
Prostate Biopsy Research Study Groups: Trans-Perineal Grid for prostate interventions
Prostate Biopsy Clinical Trial 2023: Trans-Perineal Grid Highlights & Side Effects. Trial Name: NCT05573048 — N/A
Trans-Perineal Grid (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05573048 — N/A
~6 spots leftby Dec 2025
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