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OncologyNCT07046832

Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy

A study testing Augmented Reality Guided Biopsy and Ultrasound Guided Biopsy in people with Oncology and Interventional Radiology, run by MediView XR, Inc. at 3 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This clinical feasibility evaluation is intended to further characterize and quantify the potential benefits of the FDA-cleared XR90 Augmented Reality (AR )imaging and guidance platform utilization in percutaneous soft tissue biopsy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Augmented Reality Guided Biopsy and Ultrasound Guided Biopsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
3 sitesUnited States
Study dates
27 Jun 2025to Jul 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • Willing and able to give informed consent prior to enrollment
  • Subjects in need of a diagnostic soft-tissue tumor biopsy which is the primary target for needle placement as a part of their standard of care.
  • Subjects who have met all criteria to undergo percutaneous biopsy with ultrasound.
  • Subjects with soft-tissue lesions ≥1 cm or ≤8 cm in depth
  • BMI of ≤40

Who cannot join

  • Children under the age of 18.
  • Currently pregnant at the time of the procedure
  • Not willing or able to give informed consent.
  • Subjects with pacemakers or AICDs.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites

  • NewYork-Presbyterian Weill Cornell Medical Center

    New York, New York, 10065

  • MedStar Georgetown Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hosptial Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Clinical Evaluation of an Intra-procedural 3D Needle Guidance Platform for Soft Tissue Tumors or Organs Requiring Percutaneous Biopsy as an Adjunct to Standard Image Guidance

This clinical feasibility evaluation is intended to further characterize and quantify the potential benefits of the FDA-cleared XR90 Augmented Reality (AR )imaging and guidance platform utilization in percutaneous soft tissue biopsy. This study will seek to build on the findings of safety, procedural benefits, and overall clinical feasibility shown in previous bench, cadaveric, and single-site clinical evaluations.

Read the detailed description

This clinical evaluation is needed to further characterize and quantify the potential benefits of percutaneous biopsy, assisted with the XR90 3D surgical imaging system. This continued innovative implementation of the platform as a medical device to assist in percutaneous targeted biopsy of soft tissue tumors will allow for further assessment of device functionality, operator acceptability, and additional data collection to help quantify the potential benefits of this platform. Potential benefits to the patient, to be formally proven in future studies: decreased procedure time, decreased of complications (e.g., critical structure avoidance), and ultimately, improved patient outcomes. To date, few studies have evaluated the performance of the XR90 guidance system in a clinical setting. Comparing percutaneous needle placement for biopsies of a soft tissue target with the assistance of XR90 compared to under only standard-of-care guidance will allow for the evaluation of procedure success rate, overall procedure time, and complications. This multicenter prospective randomized control trial is designed to compare the efficacy and utility of the XR90 guidance platform used adjunct to standard of care guidance to standard of care guidance (2D) only for percutaneous needle-based procedures.

Being tested
Augmented Reality Guided Biopsy, Ultrasound Guided Biopsy
Keywords
Percutaneous Interventions, Needle Guidance, Augmented Reality, Medical Device, XR90, Minimally Invasive
Medical subject headings
Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented Reality Guided BiopsyDevice

    Augmented Reality system in adjunct to standard of care guidance for needle guidance during a percutaneous biopsy

  • Ultrasound Guided BiopsyDevice

    Ultrasound guided biopsy as a part of standard of care.

Study groups in NCT07046832
Study groupRoleWhat they receive
Arm A, XR90 (Experimental Group)ExperimentalParticipants randomly assigned to this arm will undergo percutaneous biopsy procedures using the assistance of XR90 guidance system in adjunct to standard of care guidance.
Receives: Device: Augmented Reality Guided Biopsy
Arm B (Standard of Care Group)Active comparatorParticipants randomly assigned to this arm will undergo percutaneous biopsy with standard of care CT and ultrasound needle guidance only.
Receives: Device: Ultrasound Guided Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of Tumor Localization

    The time from initiation of localization of imaging (defined by when the ultrasound probe is put into operator's hand) until operator has planned a trajectory and point of entry (by placing a finger or trocar on the skin entry site and verbalizing completion of localization) will be measured and recorded. Time is recorded in minutes and will be completed during the procedure.

    Measured: Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day.

  2. Time From Skin to Target

    The elapsed time from when the proceduralist inserts their trocar or biopsy needle through the skin (excluding skin knicks) and when the provider verbalizes they have reached their intended target in order to collect a biopsy under ultrasound guidance. Time will be recorded in minutes beginning and ending during the study procedure.

    Measured: Intraprocedural, from the start of the procedure until the end of the study procedure, 1 day.

Secondary outcomes (2)

  1. Technical Success

    The completion of the biopsy procedure. Procedures will be determined to be complete once the provider has verified (via ultrasound or CT) the trocar has reached the intended target, as if the proceduralist were to ablate or biopsy

    Measured: Duration of the study procedure

  2. Needle Attempts

    An attempt will be counted at the beginning of targeting and each time an operator removes their needle from the skin and restarts localization.

    Measured: Duration of the study procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start27 Jun 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter prospective randomized control trial
Masking
Single blind
Who is masked
Participant
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07046832
Sponsor's protocol ID
24-06-433
Status last verified
Jun 2025
First submitted
13 Jun 2025
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: The trial evaluates a novel augmented reality needle guidance platform that includes investigational software features and procedural performance data. These elements are considered proprietary and form part of an active product development that may be incorporated as part of a broader regulatory strategy. In addition, the study's small sample size and highly structured procedural metrics - including EM tracking outputs, intraoperative timing, and device-specific workflow parameters - increase the risk of participant re-identification, even without direct identifiers or imaging. To protect intellectual property and ensure compliance with HIPAA, GDPR, and FDA confidentiality provisions (21 CFR § 812.38; 21 CFR § 20.61), individual participant data (IPD) will not be shared. Summary-level data and aggregate results will be made available through peer-reviewed publications and posted on ClinicalTrials.gov

Publications

  • Al-Nimer S, Hanlon A, Cho K, Kalra-Lall A, Weunski C, Yanof J, West K, Martin C 3rd. 3D Holographic Guidance and Navigation for Percutaneous Ablation of Solid Tumor. J Vasc Interv Radiol. 2020 Mar;31(3):526-528. doi: 10.1016/j.jvir.2019.09.027. Epub 2020 Jan 31. No abstract available.

    PubMed 32008844

  • Gadodia G, Yanof J, Hanlon A, Bustos S, Weunski C, West K, Martin C 3rd. Early Clinical Feasibility Evaluation of an Augmented Reality Platform for Guidance and Navigation during Percutaneous Tumor Ablation. J Vasc Interv Radiol. 2022 Mar;33(3):333-338. doi: 10.1016/j.jvir.2021.11.014.

    PubMed 35221048

Questions about this trial

What is this clinical trial studying?

A study testing Augmented Reality Guided Biopsy and Ultrasound Guided Biopsy in people with Oncology and Interventional Radiology, run by MediView XR, Inc. at 3 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 6 inclusion and 4 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Time of Tumor Localization (time frame: Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day.). 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?

On the ClinicalTrials.gov record for NCT07046832, which also lists 2 linked publications.

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 2 Jul 2025.

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