Ablation, Biopsy
Conditions
Brief summary
The purpose of this study is to evaluate the feasibility and safety of using the LUMENA guidance system during clinical procedures in patients undergoing CT-guided needle Placement for kidney, liver, lymph node, abdominal mass and lung ablation/biopsy.
Interventions
DEVICELUMENA Guidance System
LUMENA is an augmented reality needle guidance system that provides real-time visual guidance during CT-guided needle placement procedures.
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
Yes
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 CT-guided 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 the gantry of the CT scanner. * Patients who are sensitive to radiation exposure such as pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of completing the CT-guided needle placement procedure using the LUMENA guidance system | 2 years | Feasibility will be assessed as the proportion of procedures successfully completed using the LUMENA guidance system without withdrawal of the system before completion. The procedure will be considered feasible if more than 80% of procedures are completed using the system. |
| Safety of CT-guided needle placement using the LUMENA guidance system as assessed by adverse events | 2 years | Safety will be assessed by the occurrence of serious adverse events and total adverse events associated with the procedure. The safety endpoint is safe needle placement in the target without any serious adverse events and total adverse events less than 10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of needle placement | 1 day | Needle placement accuracy will be assessed by comparing the planned target location on the planning CT image set with the actual needle tip location on the confirmatory CT image set. Accuracy will be calculated as the three-dimensional distance between the planned target and actual needle tip location, reported in millimeters. |
| Procedure time | 1 day | Procedure time will be measured from acquisition of the initial imaging to acquisition of the final imaging and reported in minutes. |
| Number of intermediary CT/fluoroscopy images | 1 day | The number of intermediary CT/fluoroscopy images obtained during the procedure will be recorded as an indirect measure of radiation exposure. |
| Operator usability assessment of the LUMENA guidance system | 1 day | At the end of each procedure, the operator will complete a usability form that captures ease of use using a Likert scale and subjective clinical impressions of system use and utility. |
Countries
United States
Contacts
CONTACTNic Dybel
CONTACTJulia Santos
PRINCIPAL_INVESTIGATORDavid Sella, MD
Mayo Clinic
Outcome results
None listed