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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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This clinical evaluation is needed to further characterize and quantify the potential benefits of percutaneous biopsy, assisted with the XR90 3D surgical imaging system. This continued innovative implementation of the platform as a medical device to assist in percutaneous targeted biopsy of soft tissue tumors will allow for further assessment of device functionality, operator acceptability, and additional data collection to help quantify the potential benefits of this platform. Potential benefits to the patient, to be formally proven in future studies: decreased procedure time, decreased of complications (e.g., critical structure avoidance), and ultimately, improved patient outcomes. To date, few studies have evaluated the performance of the XR90 guidance system in a clinical setting. Comparing percutaneous needle placement for biopsies of a soft tissue target with the assistance of XR90 compared to under only standard-of-care guidance will allow for the evaluation of procedure success rate, overall procedure time, and complications. This multicenter prospective randomized control trial is designed to compare the efficacy and utility of the XR90 guidance platform used adjunct to standard of care guidance to standard of care guidance (2D) only for percutaneous needle-based procedures.

Conditions

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Oncology Interventional Radiology Liver Carcinoma Renal Carcinoma Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter prospective randomized control trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Augmented Reality Guided Biopsy

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Ultrasound Guided Biopsy

Intervention Type DEVICE

Ultrasound guided biopsy as a part of standard of care.

Interventions

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Augmented Reality Guided Biopsy

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

Intervention Type DEVICE

Ultrasound Guided Biopsy

Ultrasound guided biopsy as a part of standard of care.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No