Health TrialsbyHealthPanel

Augmented Reality Real-Time Guidance for MRI-Guided Interventions

ConditionLiver
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • MRI guided procedure software evaluation

    Device

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: MR-guided needle placementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of intervention

Use of the guidance system will be considered feasible if the system is used successfully in more than 80% of procedures

Time frame
Baseline (during procedure)
2

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%.

Time frame
Up to 4 hours

Secondary outcomes

1

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.

Time frame
Baseline (during procedure)
2

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).

Time frame
Baseline (during procedure)
3

Accuracy of needle placement

Assessed using MRI images showing needle placement, planned versus actual.

Time frame
Baseline (during procedure)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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