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

NCT ID: NCT04039529

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

Liver Biopsy; Lung Biopsy; Kidney Biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CT-only guided biopsy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

SCENERGY-guided Biopsy

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

Group Type: EXPERIMENTAL

SCENERGY-guided Biopsy

Intervention Type: DEVICE

Use of SCENERGY during a lung, liver or kidney biopsy

Interventions

SCENERGY-guided Biopsy

Use of SCENERGY during a lung, liver or kidney biopsy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Clear Guide Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Temple University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

TUH SCENERGY

Identifier Type: -

Identifier Source: org_study_id