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

NCT07046832 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • MediView XR, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-27
Primary Completion
2027-06-30
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046832 on ClinicalTrials.gov