Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Location status: Recruiting
Location contact
Emily Leibold, BSE
CONTACT
Karun Sharma, MD, PhD
CONTACT
Karun Sharma, MD/PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06224933
The purpose of this study is to determine feasibility and safety of using an augmented reality system in patients undergoing MRI-Guided needle procedures.
Interested in participating?
Request Info3 year–21 year
All sexes
Interventional
Not applicable
Washington D.C., District of Columbia, 20010, United States
Location status: Recruiting
Emily Leibold, BSE
CONTACT
Karun Sharma, MD, PhD
CONTACT
Karun Sharma, MD/PhD
PRINCIPAL_INVESTIGATOR
This pilot clinical study is designed to evaluate the feasibility of using a needle guidance system during MRI-guided procedures in up to 12 patients. The MRI-compatible needle guidance system was developed under an NIH funded SBIR Phase II grant. This system has been evaluated by our Interventional Radiology team in phantom, volunteer, and cadaver studies which showed potential benefit of use in patients. Inclusion of the needle guidance system will not change the standard of care or substantively affect procedural technique as currently performed. This system provides the operator with an augmented reality (AR) display to better visualize the needle entry point and trajectory as it is inserted toward the target. This additional information could improve needle placement accuracy and shorten procedural time.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects 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.
Time frame: 1 day
Time frame: 7 days
Time frame: 1 day
Total procedure time.
Time frame: 1 day
Number of MRI scans needed to complete the procedure, and size and depth of target will be recorded.
Time frame: 1 Day
The operator will complete a usability form that captures ease of use using the Likert scale.
Contact information is provided by the study sponsor or research team.
Children's National Research Institute
Other
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06278337
Autoimmune Diseases, Diagnosis
Bethesda, Maryland, United States
View Trial DetailsNCT06156072
Diagnosis, Disease
View Trial DetailsNCT05952999
Asthma, Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Peoria, Illinois, United States
View Trial DetailsNCT06548841
Bacterial Infections, Bacterial Infections and Mycoses
Bologna, Italy
View Trial Details