Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Augmented Reality Guided Biopsy, Ultrasound Guided Biopsy.
- Who it may be relevant to
- Registry conditions: Oncology, Interventional Radiology, Liver Carcinoma, Renal Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Time of Tumor Localization [Time frame: Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day.]
- Time From Skin to Target [Time frame: Intraprocedural, from the start of the procedure until the end of the study procedure, 1 day.]
Secondary outcome measures (2)
- Technical Success [Time frame: Duration of the study procedure]
- Needle Attempts [Time frame: Duration of the study procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
United States · 3 centers
- MedStar Georgetown Hospital — Washington D.C.
- MedStar Washington Hosptial Center — Washington D.C.
- NewYork-Presbyterian Weill Cornell Medical Center — New York
Publications
- 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
- 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
Identifiers
NCT: NCT07046832 · 24-06-433