Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biopsy | — | UNRESOLVED | — |
| Interventional Radiology | — | UNRESOLVED | — |
| Liver Carcinoma | Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oncology | — | UNRESOLVED | — |
| Renal Carcinoma | Kidney Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Augmented Reality Guided Biopsy | Device | — | UNRESOLVED |
| Ultrasound Guided Biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A, XR90 (Experimental Group)
- description
- 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.
- interventionNames
- Device: Augmented Reality Guided Biopsy
- type
- ACTIVE_COMPARATOR
- label
- Arm B (Standard of Care Group)
- description
- Participants randomly assigned to this arm will undergo percutaneous biopsy with standard of care CT and ultrasound needle guidance only.
- interventionNames
- Device: Ultrasound Guided Biopsy
Primary outcomes (2)
- measure
- Time of Tumor Localization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDAl-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
- BACKGROUNDGadodia 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