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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Detailed Description

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.

Interventions

  • Device: SCENERGY-guided Biopsy
    • Use of SCENERGY during a lung, liver or kidney biopsy

Arms, Groups and Cohorts

  • No Intervention: CT-only guided biopsy
    • The current standard of care for biopsy at Temple University Hospital.
  • Experimental: SCENERGY-guided Biopsy
    • The use of the SCENERGY to fuse CT and Ultrasound for biopsy

Clinical Trial Outcome Measures

Primary Measures

  • Radiation Dose during Procedure
    • Time Frame: 1 hour
    • The number of CTs or Fluoroscopy shots during the biopsy

Secondary Measures

  • Time to Reach Target of Biopsy
    • Time Frame: 1 hour
    • The amount of time in seconds that the physician takes to reach the target of biopsy
  • Experience Level
    • Time Frame: 1 hour
    • Number of years physician has practiced in Interventional Radiology

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clear Guide Medical
  • Collaborator
    • Temple University
  • Provider of Information About this Clinical Study
    • Sponsor

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