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

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ClinicalTrials.gov Identifier: NCT04039529
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
Temple University Hospital
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Biopsy Lung Biopsy Kidney Biopsy Device: SCENERGY-guided Biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: Masking is impossible due to the hardware that is present when using the SCENERGY
Primary Purpose: Other
Official Title: Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
No Intervention: CT-only guided biopsy
The current standard of care for biopsy at Temple University Hospital.
Experimental: SCENERGY-guided Biopsy
The use of the SCENERGY to fuse CT and Ultrasound for biopsy
Device: SCENERGY-guided Biopsy
Use of SCENERGY during a lung, liver or kidney biopsy




Primary Outcome Measures :
  1. Radiation Dose during Procedure [ Time Frame: 1 hour ]
    The number of CTs or Fluoroscopy shots during the biopsy


Secondary Outcome Measures :
  1. Time to Reach Target of Biopsy [ Time Frame: 1 hour ]
    The amount of time in seconds that the physician takes to reach the target of biopsy

  2. Experience Level [ Time Frame: 1 hour ]
    Number of years physician has practiced in Interventional Radiology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039529


Contacts
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Contact: Dorothee Heisenberg, PhD 4435703835 heisenberg@clearguidemedical.com

Locations
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United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Gary Cohen, MD    215-707-3390    gary.cohen@tuhs.temple.edu   
Sponsors and Collaborators
Clear Guide Medical
Temple University Hospital
National Institutes of Health (NIH)

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Responsible Party: Clear Guide Medical
ClinicalTrials.gov Identifier: NCT04039529     History of Changes
Other Study ID Numbers: TUH SCENERGY
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Clear Guide Medical:
lung biopsy
kidney biopsy
liver biopsy
image fusion