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Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy
Sponsor: MediView XR, Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2025-06-27
Completion Date
2027-07
Last Updated
2025-07-02
Healthy Volunteers
No
Interventions
Augmented Reality Guided Biopsy
Augmented Reality system in adjunct to standard of care guidance for needle guidance during a percutaneous biopsy
Ultrasound Guided Biopsy
Ultrasound guided biopsy as a part of standard of care.
Locations (3)
MedStar Georgetown Hospital
Washington D.C., District of Columbia, United States
MedStar Washington Hosptial Center
Washington D.C., District of Columbia, United States
NewYork-Presbyterian Weill Cornell Medical Center
New York, New York, United States