Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy

Clinical Trial ID: NCT04039529

Description

This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.

This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.


Criteria

Inclusion Criteria: - all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy. Exclusion Criteria: - any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.

  • Start Date

    2019-08-31

  • Last Updated

    2019-07-30

  • Sponsor

    National Institutes of Health (NIH)

  • Condition Name

    Kidney Biopsy

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