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Patients Undergoing Augmented Reality Image-Guided Needle Procedures for Pain

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

Select...

I am referred for a procedure using imaging to guide needle use.

Select...

I am between 3 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.

Safety of using the augmented reality needle guidance system will be evaluated through assessment of procedure related adverse events that occur within 7 days of the procedure.

Secondary outcome measures

Clinical impressions of the system use and utility

Number of MRI scans

Procedure time

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

208,145 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently ongoing for this research study?

"Indeed, clinicaltrials.gov reports that this ongoing medical trial is actively seeking eligible participants. The study was initially posted on February 20th, 2024 and underwent the most recent update on January 24th, 2024."

Answered by AI

Is it possible for me to enroll as a participant in this research study?

"To be deemed eligible for this clinical trial, patients must have a confirmed infection and fall within the age range of 3 to 21 years. The study aims to enroll approximately 12 participants."

Answered by AI

What is the current number of participants undergoing examination in this particular investigation?

"Indeed, according to the information available on clinicaltrials.gov, this ongoing clinical trial is actively seeking participants. The study was initially posted on February 20th, 2024 and last updated on January 24th, 2024. They aim to recruit a total of 12 individuals from one designated site."

Answered by AI

Are individuals aged 65 and above being actively recruited for participation in this study?

"To be considered eligible for this research study, applicants must fall within the age range of 3 to 21. There are a total of 259 trials available for patients under the age of 18 and 865 trials specifically designed for patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Augmented Reality For MRI-Guided Interventions

Karun Sharma MD 2024. "Augmented Reality For MRI-Guided Interventions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06224933.

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