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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,125 Total Patients Enrolled
Clear Guide Medical Inc.UNKNOWN
David Woodrum, MD, PhDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
119 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a biopsy or ablation guided by MRI.You are able to handle being put under anesthesia or sedation.I have had cancer other than skin cancer in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Trans-Perineal Grid for prostate interventions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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