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

Clear Guide Medical

Status: Withdrawn

Conditions: Liver Biopsy; Lung Biopsy; Kidney Biopsy

Treatments: Device: SCENERGY-guided Biopsy

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04039529

TUH SCENERGY

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

CT-only guided biopsy

No Intervention group

Description:

The current standard of care for biopsy at Temple University Hospital.

SCENERGY-guided Biopsy

Experimental group

Description:

The use of the SCENERGY to fuse CT and Ultrasound for biopsy

Treatment:

Device: SCENERGY-guided Biopsy