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

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.

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.

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.