Liver
Conditions
Brief summary
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
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of intervention | Baseline (during procedure) | Use of the guidance system will be considered feasible if the system is used successfully in more than 80% of procedures |
| Safety of intervention (adverse events) | Up to 4 hours | Participants will be monitored for adverse events during the procedure and during recovery time following the procedure. The intervention will be considered safe if the needle is successfully placed in the target with no serious adverse events and total adverse events \<10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of needle passes | Baseline (during procedure) | Recorded during the procedure by a member of the technical staff who will be there monitoring use of the guidance system. |
| Procedure time | Baseline (during procedure) | Procedure time will be recorded. Start time will be when initial imaging is obtained (planning image). The end time will be when the final imaging is taken (needle placement completed). |
| Accuracy of needle placement | Baseline (during procedure) | Assessed using MRI images showing needle placement, planned versus actual. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid A. Woodrum, MD, PhD
Mayo Clinic
Outcome results
None listed