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

Enrolling by invitation · Not applicable

Conditions studied: Oncology, Interventional Radiology, Liver Carcinoma, Renal Carcinoma, Biopsy

In brief

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.

Key facts

Study ID

NCT07046832

Run by

MediView XR, Inc.

People needed

104

Starts

2025-06-27

Expected to finish

2027-07-01

Last updated by the study team

2025-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.