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

Not Applicable

Withdrawn

• Conditions: Liver Biopsy; Kidney Biopsy; Lung Biopsy
• Interventions: Device: SCENERGY-guided Biopsy

• Registration Number: NCT04039529
• Lead Sponsor: Clear Guide Medical

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-07-31
• Study Start: 2019-12-31
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCENERGY-guided Biopsy	SCENERGY-guided Biopsy	The use of the SCENERGY to fuse CT and Ultrasound for biopsy

Primary Outcome Measures

Name	Time	Method
Radiation Dose during Procedure	1 hour	The number of CTs or Fluoroscopy shots during the biopsy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States