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EM Tracking Devices for Biopsy Accuracy in Kidney and Prostate Cancer
N/A
Waitlist Available
Led By Bradford J Wood, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years
Be older than 18 years old
Must not have
Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is exploring whether a new tracking device can help place needles more accurately during biopsy or ablation procedures.
Who is the study for?
Adults over 18 needing a biopsy or ablation guided by CT, with lesions hard to locate using standard imaging. They must understand and agree to the study's terms, be able to lie still during the procedure, and not have severe illnesses affecting decision-making. Excluded are those over 606 pounds, unable to hold their breath if needed, mentally unable to consent, or with pacemakers/electrical implants.
What is being tested?
The trial is testing an experimental 'smart needle' equipped with a tracking device for better accuracy in locating hard-to-find abnormalities during invasive procedures like biopsies. It works like mini GPS inside the body using weak magnets and aims to improve needle placement.
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with invasive procedures such as pain at the insertion site, bleeding, infection risk from needles used in biopsies or ablations, 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 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can't stay still for long periods on a procedure table.
Select...
I am unable to understand or consent to a biopsy due to my mental condition.
Select...
I cannot hold my breath if I need to be awake during a procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of using electromagnetic devices in different cohorts.
Secondary study objectives
Success of ablation as determined by imaging
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: All cohorts (prostate biopsy percutaneous biopsy and ablation)Experimental Treatment1 Intervention
This study will consist of comparison of tracked imaging with near-simultaneous actual imaging .
Find a Location
Who is running the clinical trial?
National Institutes of Health Clinical Center (CC)Lead Sponsor
389 Previous Clinical Trials
30,875,997 Total Patients Enrolled
Bradford J Wood, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
8 Previous Clinical Trials
203 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a prostate MRI showing abnormalities and need a biopsy.I can't stay still for long periods on a procedure table.I am unable to understand or consent to a biopsy due to my mental condition.I cannot hold my breath if I need to be awake during a procedure.I am scheduled for a procedure like angiography or a CT/US-guided biopsy.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: All cohorts (prostate biopsy percutaneous biopsy and ablation)
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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