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Augmented Reality for Biopsies
N/A
Recruiting
Led By Karun Sharma, MD, PhD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.
Male or female, ages 3 to 21
Must not have
Patients over 300 pounds
Patients who are unable to give informed consent themselves or through their parents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if using a virtual reality system during MRI-guided needle procedures is safe and possible.
Who is the study for?
This trial is for patients who need MRI-guided needle procedures, such as biopsies or treatments for infections and pain. The study aims to test if using an augmented reality system can help with these procedures.
What is being tested?
The intervention being studied is an augmented reality system designed to assist during MRI-guided needle interventions. The trial will assess the feasibility and safety of this technology in a clinical setting.
What are the potential side effects?
Since this trial involves a non-invasive technology, side effects may be minimal but could include discomfort from wearing the device or potential distractions leading to procedural complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am referred for a procedure using imaging to guide needle use.
Select...
I am between 3 and 21 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I weigh over 300 pounds.
Select...
I cannot give consent for the trial myself or through my parents.
Select...
I am under 3 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Clinical impressions of the system use and utility
Number of MRI scans
Procedure time
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: Patients Undergoing Augmented Reality Image-Guided Needle ProceduresExperimental Treatment1 Intervention
Patients will undergo their standard of care image-guided needle biopsy, aspiration, or injection with the Augmented Reality system. Patients will be monitored for adverse events for two weeks following their procedure.
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Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
221 Previous Clinical Trials
258,358 Total Patients Enrolled
2 Trials studying Pain
322 Patients Enrolled for Pain
Karun Sharma, MD, PhDPrincipal InvestigatorChildren's National Research Institute
2 Previous Clinical Trials
39 Total Patients Enrolled
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