Augmented Reality Real-Time Guidance for MRI-Guided Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI guided procedure software evaluation.
- Who it may be relevant to
- Registry conditions: Liver. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures.
Detailed description
The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures.
The MRI compatible guidance system will not change the needle biopsy or ablation procedure but will provide the doctor doing the procedure with an augmented reality display to better track the needle path as it is being inserted in the target. Otherwise, the procedure will be carried out in the same manner as it is currently done under MRI or CT or X-ray guidance.
Participants who have been scheduled for the guided biopsy or ablation procedure of the liver will be invited to take part in this research.
Study participation involves one study visit. Participants will be in the study until the biopsy or ablation procedure is completed. The biopsy procedure will take approximately 60 minutes to complete. The ablation procedure will take approximately 4 hours to complete.
Interventions
- Device MRI guided procedure software evaluation
For the use of the MRI-needle guidance system (LUMENA) developed by CLEAR GUIDE MEDICAL during clinical MRI-guided needle placement procedures for patients undergoing a liver biopsy/procedure.
Primary outcome measures
- Feasibility of intervention [Time frame: Baseline (during procedure)]
- Safety of intervention (adverse events) [Time frame: Up to 4 hours]
Secondary outcome measures (3)
- Number of needle passes [Time frame: Baseline (during procedure)]
- Procedure time [Time frame: Baseline (during procedure)]
- Accuracy of needle placement [Time frame: Baseline (during procedure)]
Eligibility criteria
Inclusion criteria
- 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 18-90 years
- Patient referred to Interventional Radiology for image-guided liver needle placement for ablation/biopsy.
Exclusion criteria
- Patients who are unable to give informed consent themselves or through their parents.
- Patients that do not fit into MR scanner (70 cm bore) with room for needle placement.
- Contraindications to MRI such as MR-unsafe implants.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 2 centers
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07120906 · 24-011504