LiverNCT07120906
Augmented Reality Real-Time Guidance for MRI-Guided Interventions
A study testing MRI guided procedure software evaluation in people with Liver, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver
- What is being tested?
- MRI guided procedure software evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- 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 image-guided liver 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 MR scanner (70 cm bore) with room for needle placement.
- Contraindications to MRI such as MR-unsafe implants.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures.
Read the detailed description
The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures.
The MRI compatible guidance system will not change the needle biopsy or ablation procedure but will provide the doctor doing the procedure with an augmented reality display to better track the needle path as it is being inserted in the target. Otherwise, the procedure will be carried out in the same manner as it is currently done under MRI or CT or X-ray guidance.
Participants who have been scheduled for the guided biopsy or ablation procedure of the liver will be invited to take part in this research.
Study participation involves one study visit. Participants will be in the study until the biopsy or ablation procedure is completed. The biopsy procedure will take approximately 60 minutes to complete. The ablation procedure will take approximately 4 hours to complete.
- Conditions
- Liver
- Being tested
- MRI guided procedure software evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI guided procedure software evaluationDevice
For the use of the MRI-needle guidance system (LUMENA) developed by CLEAR GUIDE MEDICAL during clinical MRI-guided needle placement procedures for patients undergoing a liver biopsy/procedure.
| Study group | Role | What they receive |
|---|---|---|
| MR-guided needle placement | Experimental | An augmented reality display compatible with MRI will be used to assist with guidance of needle placement for biopsy or ablation procedure. Receives: Device: MRI guided procedure software evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Use of the guidance system will be considered feasible if the system is used successfully in more than 80% of procedures
Measured: Baseline (during procedure)
Safety of intervention (adverse events)
Participants will be monitored for adverse events during the procedure and during recovery time following the procedure. The intervention will be considered safe if the needle is successfully placed in the target with no serious adverse events and total adverse events <10%.
Measured: Up to 4 hours
Secondary outcomes (3)
Number of needle passes
Recorded during the procedure by a member of the technical staff who will be there monitoring use of the guidance system.
Measured: Baseline (during procedure)
Procedure time
Procedure time will be recorded. Start time will be when initial imaging is obtained (planning image). The end time will be when the final imaging is taken (needle placement completed).
Measured: Baseline (during procedure)
Accuracy of needle placement
Assessed using MRI images showing needle placement, planned versus actual.
Measured: Baseline (during procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start25 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiverStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A. Woodrum, Mayo Clinic
- Investigators
- David A. Woodrum, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120906
- Sponsor's protocol ID
- 24-011504
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality Real-Time Guidance for MRI-Guided Interventions
- ClinicalTrials.gov ID
- NCT07120906
- Acronym / sponsor ID
- 24-011504
- Conditions
- Liver
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures.
Detailed description
The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures.
The MRI compatible guidance system will not change the needle biopsy or ablation procedure but will provide the doctor doing the procedure with an augmented reality display to better track the needle path as it is being inserted in the target. Otherwise, the procedure will be carried out in the same manner as it is currently done under MRI or CT or X-ray guidance.
Participants who have been scheduled for the guided biopsy or ablation procedure of the liver will be invited to take part in this research.
Study participation involves one study visit. Participants will be in the study until the biopsy or ablation procedure is completed. The biopsy procedure will take approximately 60 minutes to complete. The ablation procedure will take approximately 4 hours to complete.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-guided needle placement | Experimental | Device: MRI guided procedure software evaluationAn augmented reality display compatible with MRI will be used to assist with guidance of needle placement for biopsy or ablation procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 image-guided liver needle placement for ablation/biopsy.
Key exclusion criteria (3 listed)
- Patients who are unable to give informed consent themselves or through their parents.
- Patients that do not fit into MR scanner (70 cm bore) with room for needle placement.
- Contraindications to MRI such as MR-unsafe implants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI guided procedure software evaluationFor the use of the MRI-needle guidance system (LUMENA) developed by CLEAR GUIDE MEDICAL during clinical MRI-guided needle placement procedures for patients undergoing a liver biopsy/procedure. | Device | MR-guided needle placement |
Primary outcome
Feasibility of intervention
Time frame: Baseline (during procedure)
Use of the guidance system will be considered feasible if the system is used successfully in more than 80% of procedures
Safety of intervention (adverse events)
Time frame: Up to 4 hours
Participants will be monitored for adverse events during the procedure and during recovery time following the procedure. The intervention will be considered safe if the needle is successfully placed in the target with no serious adverse events and total adverse events <10%.
3 secondary outcomes
Number of needle passes
Time frame: Baseline (during procedure)
Procedure time
Time frame: Baseline (during procedure)
Accuracy of needle placement
Time frame: Baseline (during procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David A. Woodrum, MD, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI guided procedure software evaluation in people with Liver, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: Baseline (during procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.