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

Liver Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04039529
• Other study ID #: TUH SCENERGY
• Status: Withdrawn
• Phase: N/A
• Start date: December 31, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2023
• Source: Clear Guide Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Biopsy
• Liver Biopsy
• Lung Biopsy

Intervention

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

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Clear Guide Medical	National Institutes of Health (NIH), Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Dose during Procedure	The number of CTs or Fluoroscopy shots during the biopsy	1 hour
Secondary	Time to Reach Target of Biopsy	The amount of time in seconds that the physician takes to reach the target of biopsy	1 hour
Secondary	Experience Level	Number of years physician has practiced in Interventional Radiology	1 hour