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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Ultrasound Guided Biopsy: Ultrasound guided biopsy as a part of standard of care.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (3)

Other trials for the same condition