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

NCT07046832 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 24-06-433
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Percutaneous Interventions; Needle Guidance; Augmented Reality; Medical Device; XR90; Minimally Invasive

Outcome Measures

Primary Outcomes (2)

• Time of Tumor Localization

  The time from initiation of localization of imaging (defined by when the ultrasound probe is put into operator's hand) until operator has planned a trajectory and point of entry (by placing a finger or trocar on the skin entry site and verbalizing completion of localization) will be measured and recorded. Time is recorded in minutes and will be completed during the procedure.

  Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day.

• Time From Skin to Target

  The elapsed time from when the proceduralist inserts their trocar or biopsy needle through the skin (excluding skin knicks) and when the provider verbalizes they have reached their intended target in order to collect a biopsy under ultrasound guidance. Time will be recorded in minutes beginning and ending during the study procedure.

  Intraprocedural, from the start of the procedure until the end of the study procedure, 1 day.

Secondary Outcomes (2)

• Technical Success

  Duration of the study procedure

• Needle Attempts

  Duration of the study procedure

Study Arms (2)

Arm A, XR90 (Experimental Group)

EXPERIMENTAL

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.

Device: Augmented Reality Guided Biopsy

Arm B (Standard of Care Group)

ACTIVE COMPARATOR

Participants randomly assigned to this arm will undergo percutaneous biopsy with standard of care CT and ultrasound needle guidance only.

Device: Ultrasound Guided Biopsy

Interventions

Augmented Reality Guided Biopsy DEVICE

Augmented Reality system in adjunct to standard of care guidance for needle guidance during a percutaneous biopsy

Arm A, XR90 (Experimental Group)

Ultrasound Guided Biopsy DEVICE

Ultrasound guided biopsy as a part of standard of care.

Arm B (Standard of Care Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MediView XR, Inc.: lead

Study Sites (3)

MedStar Georgetown Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hosptial Center

Washington D.C., District of Columbia, 20010, United States

Location

NewYork-Presbyterian Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Related Publications (2)

• Al-Nimer S, Hanlon A, Cho K, Kalra-Lall A, Weunski C, Yanof J, West K, Martin C 3rd. 3D Holographic Guidance and Navigation for Percutaneous Ablation of Solid Tumor. J Vasc Interv Radiol. 2020 Mar;31(3):526-528. doi: 10.1016/j.jvir.2019.09.027. Epub 2020 Jan 31. No abstract available.

  PMID: 32008844 BACKGROUND

• Gadodia G, Yanof J, Hanlon A, Bustos S, Weunski C, West K, Martin C 3rd. Early Clinical Feasibility Evaluation of an Augmented Reality Platform for Guidance and Navigation during Percutaneous Tumor Ablation. J Vasc Interv Radiol. 2022 Mar;33(3):333-338. doi: 10.1016/j.jvir.2021.11.014.

  PMID: 35221048 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Carcinoma, Hepatocellular; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter prospective randomized control trial

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 2, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)