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NCT07046832

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

Enrolling by Invitation
NAAges 18+InterventionalDiagnostic
MediView XR, Inc.
~104 participants
Updated 2025-07-02 on ClinicalTrials.gov
What's tested:Augmented Reality Guided BiopsyUltrasound Guided Biopsy

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time of Tumor Localization
Measured over Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day.
+1 more outcome measured

Conditions

Oncology
Interventional Radiology
Liver Carcinoma
Renal Carcinoma
Biopsy

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Where it's being run

3 sites across 2 states
District of Columbia2
New York1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Time of Tumor LocalizationIntraprocedural-from the start of the procedure until the end of the study procedure, 1 day.

    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.

  • Time From Skin to TargetIntraprocedural, from the start of the procedure until the end of the study procedure, 1 day.

    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.