Biopsy, Interventional Radiology, Liver Carcinoma, Oncology, Renal Carcinoma
Conditions
Keywords
Percutaneous Interventions, Needle Guidance, Augmented Reality, Medical Device, XR90, Minimally Invasive
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.
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
DEVICEAugmented Reality Guided Biopsy
Augmented Reality system in adjunct to standard of care guidance for needle guidance during a percutaneous biopsy
DEVICEUltrasound Guided Biopsy
Ultrasound guided biopsy as a part of standard of care.
Sponsors
MediView XR, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
Multicenter prospective randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Tumor Localization | Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day. | 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. |
| Time From Skin to Target | Intraprocedural, from the start of the procedure until the end of the study procedure, 1 day. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Needle Attempts | Duration of the study procedure | An attempt will be counted at the beginning of targeting and each time an operator removes their needle from the skin and restarts localization. |
| Technical Success | Duration of the study procedure | The completion of the biopsy procedure. Procedures will be determined to be complete once the provider has verified (via ultrasound or CT) the trocar has reached the intended target, as if the proceduralist were to ablate or biopsy |
Countries
United States
Outcome results
None listed