Augmented Reality For MRI-Guided Interventions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-21
SponsorChildren's National Research Institute
About this trial
The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, ages 3 to 21
Patient referred to Interventional Radiology for image-guided needle injection, aspiration, or biopsy.
Disqualifiers
Patients who are unable to give informed consent themselves or through their parents.
Patients under 3 years of age
Patients over 300 pounds.
Patients who are claustrophobic and unable to tolerate MRI-guided procedure.
Trial design
Design model
Single group
Treatments tested in this trial
Augmented Reality System
DeviceSubjects will undergo image guided needle aspiration, injection, or biopsy facilitated by the Augmented Reality system. The Augmented Reality guidance system will be operated by the interventional radiologist in the MRI suite.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Patients Undergoing Augmented Reality Image-Guided Needle ProceduresExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility is measured by successful completion of greater than 80% of cases using the augmented reality needle guidance system.
Time frame
1 day2
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.
Time frame
7 daysSecondary outcomes
1
Procedure time
Total procedure time.
Time frame
1 day2
Number of MRI scans
Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded.
Time frame
1 day3
Clinical impressions of the system use and utility
The operator will complete a usability form that captures ease of use using the Likert scale.
Time frame
1 DaySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov