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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-guided needle placement | Experimental | An augmented reality display compatible with MRI will be used to assist with guidance of needle placement for biopsy or ablation procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI guided procedure software evaluation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of intervention | Use of the guidance system will be considered feasible if the system is used successfully in more than 80% of procedures | Baseline (during procedure) |
| Safety of intervention (adverse events) | 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%. | Up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of needle passes | Recorded during the procedure by a member of the technical staff who will be there monitoring use of the guidance system. | Baseline (during procedure) |
| Procedure time | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Desirae Howe-Clayton | Contact | 507-255-0111 | Howe.Desirae@mayo.edu | |
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| David A. Woodrum, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Not yet recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Baseline (during procedure) |
| Accuracy of needle placement | Assessed using MRI images showing needle placement, planned versus actual. | Baseline (during procedure) |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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