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NCT07046832Enrolling by invitation

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

Source: ClinicalTrials.gov · Last updated 2 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
104 (estimated)
First submitted
13 Jun 2025
Start date
27 Jun 2025
Primary completion date
Jun 2027
Lead sponsor
MediView XR, Inc.
NCT number
NCT07046832

What you commit to

  • Study type: Interventional
  • Planned participants: 104
  • From 27 Jun 2025 to the primary completion date, Jun 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Children under the age of 18.

Other

  • Currently pregnant at the time of the procedure
  • Not willing or able to give informed consent.
  • Subjects with pacemakers or AICDs.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NewYork-Presbyterian Weill Cornell Medical Center
Coordinator of this site? Confirm its status		New YorkUnited StatesUnknown status
MedStar Georgetown Hospital
Coordinator of this site? Confirm its status		Washington D.C.United StatesUnknown status
MedStar Washington Hosptial Center
Coordinator of this site? Confirm its status		Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.