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Trial record 3 of 8 for:    clear guide medical

Ultrasound-CT Fusion System for Interventional Radiology Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226535
Recruitment Status : Unknown
Verified July 2017 by Clear Guide Medical.
Recruitment status was:  Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Clear Guide Medical

Tracking Information
First Submitted Date  ICMJE July 18, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE June 22, 2017
Estimated Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2017)
Number of CT scans or CT fluoroscopic images [ Time Frame: Immediately following intervention (within 2 hours) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2017)
  • Total procedure time [ Time Frame: Immediately following intervention (within 2 hours) ]
    Time from the first CT scan until the needle is at the target
  • Time to target [ Time Frame: Immediately following intervention (within 2 hours) ]
    Time from needle entering the skin until the needle is at the target
  • Success of needle placement [ Time Frame: Immediately following intervention (within 2 hours) ]
    A confirmatory CT will be performed to check if the needle reached the target
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound-CT Fusion System for Interventional Radiology Procedures
Official Title  ICMJE Ultrasound-CT Fusion System for Interventional Radiology Procedures
Brief Summary The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time ultrasound that is being performed on the patient. This fusion system will be used to perform ultrasound guided needle placements for patients undergoing percutaneous CT guided needle-based intervention. This study will consist of 20 patients, 10 patients using the CGM SCENERGY US-CT system and 10 patients using guidance only. The primary goal of the study is to prove that the new imaging fusion system is comparable to using either CT or US guidance alone to guide needle placement.
Detailed Description

A simple 20 patient study will be performed using the CG SCENERGY system. This fusion system will be used to perform image guided needle placements for patients undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis). Only patients who are already scheduled for a CT guided procedure will be screened. The study design is as follows:

  • 10 patients will have their procedure performed using the CGM SCENERGY US-CT fusion system and 10 patients will have their procedure performed using CT guidance only.
  • Proper informed consent will be obtained
  • Perform a CT scan with the optical adhesive skin markers in place. Markers are placed around the expected site of needle skin entry.
  • The first 10 patients Group#1 (1-10) will be assigned to using the SCENERGY fusion system to complete the needle placement, and the next 10 patients Group #2 (11-20) will be assigned of continuing with CT guidance only to complete the needle placement.
  • If in Group #1, the procedure will proceed as usual using the SCENERGY system to guide the needle to target. If in the Group #2, CT guidance will be used to place the needle to target.
  • Once the needle is at the target, a confirmatory CT will be performed.

    • If the target is reached (i.e., the software directed the interventional radiologist to the right place, e.g. for correctly biopsying a lesion), the trial is considered a "success" and the procedure continues as normal.
    • If the needle is not in the right place, the trial is considered a "failure", and the procedure continues as normal without using the CGM software any further.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • CT Guided Biopsy
  • CT Guided Drain Placement Within the Abdomen or Pelvis
  • CT Guided Injection of Muscle or Nerve Within the Pelvis
Intervention  ICMJE Device: Ultrasound-CT Fusion
The Clear Guide SCENERGY is an Ultrasound-CT fusion device which supplements existing ultrasound and CT capabilities. The participants randomly selected (out of 20 patients) for use of the Clear Guide SCENERGY (test group) will receive ultrasound-CT fusion guidance from the MDs performing the procedure.
Other Name: Clear Guide SCENERGY
Study Arms  ICMJE
  • Experimental: Ultrasound-CT Fusion Guidance
    The participants in this group (test group) will utilize the ultrasound-CT fusion system for guiding needle placement.
    Intervention: Device: Ultrasound-CT Fusion
  • No Intervention: CT Guidance
    The participants in this group (control group) will receive the procedure with traditional CT methods and equipment, for guiding needle placement.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 20, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 22, 2018
Estimated Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis)
  • Able to give written informed consent

Exclusion Criteria:

  • Unable to give informed consent
  • Patients undergoing CT guided needle-based interventions other than the procedures mentioned in the inclusion criteria
  • Prisoners, pregnant women, and children
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03226535
Other Study ID Numbers  ICMJE CGM 17-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Clear Guide Medical
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Clear Guide Medical
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Brian Holly, MD Johns Hopkins University
PRS Account Clear Guide Medical
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP