NCT04039529

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Clear Guide Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Liver Biopsy
• Lung Biopsy
• Kidney Biopsy

Interventions

Type	Name	Description
DEVICE	SCENERGY-guided Biopsy	Use of SCENERGY during a lung, liver or kidney biopsy

Timeline

• Start date: 2019-12-31
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-07-31
• Last updated: 2023-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study