BiopsyNCT07822425
A Study Of Augmented Reality Real-Time Guidance With In-situ Feedback
A study testing LUMENA Guidance System in people with Biopsy and Ablation, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- What is being tested?
- LUMENA Guidance System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2026to 16 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Riley Nichols, 904-953-7783
David Sella, MD
About this study
Official title: 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.
- Being tested
- LUMENA Guidance System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUMENA Guidance SystemDevice
LUMENA is an augmented reality needle guidance system that provides real-time visual guidance during CT-guided needle placement procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LUMENA Guidance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start17 Sep 2026 (estimated)
- Primary completion16 Sep 2028 (estimated)
- Study completion16 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiopsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Sella, Mayo Clinic
- Investigators
- David Sella, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822425
- Sponsor's protocol ID
- 26-002714
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No