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

Augmented Reality Real-Time Guidance With In-situ Feedback

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.

Study Overview

• Status: Recruiting
• Conditions: Ablation; Biopsy
• Intervention / Treatment: Device: LUMENA Guidance System

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia Santos; Phone Number: 904-953-3280; Email: santos.julia@mayo.edu
• Study Contact Backup: Name: Nic Dybel; Phone Number: 904-953-4324; Email: dybel.nicolas@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Contact: Riley Nichols; Phone Number: 904-953-7783
      • Principal Investigator: David Sella, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of completing the CT-guided needle placement procedure using the LUMENA guidance system	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.	2 years
Safety of CT-guided needle placement using the LUMENA guidance system as assessed by adverse events	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%.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of needle placement	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.	1 day
Procedure time	Procedure time will be measured from acquisition of the initial imaging to acquisition of the final imaging and reported in minutes.	1 day
Number of intermediary CT/fluoroscopy images	The number of intermediary CT/fluoroscopy images obtained during the procedure will be recorded as an indirect measure of radiation exposure.	1 day
Operator usability assessment of the LUMENA guidance system	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.	1 day

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: David Sella, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): September 17, 2026
• Primary Completion (Estimated): September 16, 2028
• Study Completion (Estimated): September 16, 2028

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 26-002714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes