NCT07046832

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: MediView XR, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Oncology
• Interventional Radiology
• Liver Carcinoma
• Renal Carcinoma
• Biopsy

Interventions

Type	Name	Description
DEVICE	Augmented Reality Guided Biopsy	Augmented Reality system in adjunct to standard of care guidance for needle guidance during a percutaneous biopsy
DEVICE	Ultrasound Guided Biopsy	Ultrasound guided biopsy as a part of standard of care.

Timeline

• Start date: 2025-06-27
• Primary completion: 2027-06-01
• Completion: 2027-07-01
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study