A Study Of Augmented Reality Real-Time Guidance With In-situ Feedback

Purpose

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.

Conditions

  • Biopsy
  • Ablation

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LUMENA Augmented Reality Guidance 		Participants will undergo clinically indicated CT-guided needle placement for ablation or biopsy with use of the LUMENA augmented reality guidance system.
  • Device: LUMENA Guidance System
    LUMENA is an augmented reality needle guidance system that provides real-time visual guidance during CT-guided needle placement procedures.

Recruiting Locations

Mayo Clinic
Jacksonville, Florida 32224
Contact:
Riley Nichols
904-953-7783

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Nic Dybel
904-953-4324
dybel.nicolas@mayo.edu