Ultrasound-CT Fusion System for Interventional Radiology Procedures

• ClinicalTrials.gov Identifier: NCT03226535
• Recruitment Status: Unknown
• First Posted: July 21, 2017
• Last Update Posted: July 21, 2017
• Sponsor: Clear Guide Medical
• Collaborator: Johns Hopkins University
• Information provided by (Responsible Party): Clear Guide Medical

Tracking Information

• First Submitted Date: July 18, 2017
• First Posted Date: July 21, 2017
• Last Update Posted Date: July 21, 2017
• Actual Study Start Date: June 22, 2017
• Estimated Primary Completion Date: June 22, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 20, 2017): Number of CT scans or CT fluoroscopic images [ Time Frame: Immediately following intervention (within 2 hours) ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ultrasound-CT Fusion System for Interventional Radiology Procedures
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• CT Guided Biopsy
• CT Guided Drain Placement Within the Abdomen or Pelvis
• CT Guided Injection of Muscle or Nerve Within the Pelvis

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 20, 2017): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 22, 2018
• Estimated Primary Completion Date: June 22, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03226535
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Clear Guide Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: Clear Guide Medical
• Original Study Sponsor: Same as current
• Collaborators: Johns Hopkins University

Investigators

• Principal Investigator: Brian Holly, MD; Johns Hopkins University

• PRS Account: Clear Guide Medical
• Verification Date: July 2017