By InvitationNot Applicable

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

United States104 participantsStarted 2025-06-27

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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 they're measuring

Time of Tumor Localization

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

Time From Skin to Target

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

Trial details

NCT IDNCT07046832

SponsorMediView XR, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

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