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

NCT07822425 | Recruiting FDA Device

• 1 other identifier: 26-002714
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Biopsy; Ablation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Accuracy of needle placement

  1 day

• Procedure time

  1 day

• Number of intermediary CT/fluoroscopy images

  1 day

• Operator usability assessment of the LUMENA guidance system

  1 day

Study Arms (1)

LUMENA Augmented Reality Guidance

EXPERIMENTAL

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

Interventions

LUMENA Guidance System DEVICE

LUMENA is an augmented reality needle guidance system that provides real-time visual guidance during CT-guided needle placement procedures.

LUMENA Augmented Reality Guidance

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Study Officials

• David Sella, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nic Dybel

CONTACT

904-953-4324; dybel.nicolas@mayo.edu

Julia Santos

CONTACT

904-953-3280; santos.julia@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): September 16, 2028
• Study Completion (Estimated): September 16, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)