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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
MediView XR, Inc.
Study ID
NCT07046832
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jun 27, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm A, XR90 (Experimental Group)
    Participants randomly assigned to this arm will undergo percutaneous biopsy procedures using the assistance of XR90 guidance system in adjunct to standard of care guidance.
  • Active Comparator: Arm B (Standard of Care Group)
    Participants randomly assigned to this arm will undergo percutaneous biopsy with standard of care CT and ultrasound needle guidance only.

Primary Outcome Measure

Time of Tumor Localization [ Time Frame: Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day. ]

Locations (3)

FacilityCityStateZIPSite coordinators
MedStar Georgetown HospitalWashington D.C.District of Columbia20007-
MedStar Washington Hosptial CenterWashington D.C.District of Columbia20010-
NewYork-Presbyterian Weill Cornell Medical CenterNew YorkNew York10065-

Find similar trials in Washington D.C., DC

By research site
MedStar Georgetown Hospital· Washington D.C., DCMedStar Washington Hosptial Center· Washington D.C., DCNewYork-Presbyterian Weill Cornell Medical Center· New York, NY

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