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

NCT04039529 | Withdrawn FDA Device

• 1 other identifier: TUH SCENERGY
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Biopsy; Lung Biopsy; Kidney Biopsy

Keywords

lung biopsy; kidney biopsy; liver biopsy; image fusion

Outcome Measures

Primary Outcomes (1)

• Radiation Dose during Procedure

  The number of CTs or Fluoroscopy shots during the biopsy

  1 hour

Secondary Outcomes (2)

• Time to Reach Target of Biopsy

  1 hour

• Experience Level

  1 hour

Study Arms (2)

CT-only guided biopsy

NO INTERVENTION

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

SCENERGY-guided Biopsy

EXPERIMENTAL

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

Device: SCENERGY-guided Biopsy

Interventions

SCENERGY-guided Biopsy DEVICE

Use of SCENERGY during a lung, liver or kidney biopsy

SCENERGY-guided Biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clear Guide Medical: lead
• Temple University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is impossible due to the hardware that is present when using the SCENERGY
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: testing whether biopsies and ablations performed with the SCENERGY result in less patient radiation dose or reduced procedure time compared to biopsies performed under CT-guidance only.

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: December 31, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)