Ultrasound-CT Fusion System for Interventional Radiology Procedures

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.

Study Overview

• Status: Unknown
• Conditions: CT Guided Biopsy; CT Guided Drain Placement Within the Abdomen or Pelvis; CT Guided Injection of Muscle or Nerve Within the Pelvis
• Intervention / Treatment: Device: Ultrasound-CT Fusion

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
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Contact: Brian Holly, MD; Phone Number: 410-614-1622; Email: bholly3@jhmi.edu
      • Contact: Taylor Dunklin, DA; Phone Number: 410-502-5118; Email: tdunkli1@jhmi.edu
      • Sub-Investigator: Douglas Yim, MD
      • Sub-Investigator: Clifford Weiss, MD
      • Principal Investigator: Brian Holly, MD
      • Sub-Investigator: Taylor Dunklin, DA
      • Sub-Investigator: Beatriz Kohler, RN, MBA, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound-CT Fusion Guidance; The participants in this group (test group) will utilize the ultrasound-CT fusion system for guiding needle placement.	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 Names: Clear Guide SCENERGY
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of CT scans or CT fluoroscopic images	Immediately following intervention (within 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedure time	Time from the first CT scan until the needle is at the target	Immediately following intervention (within 2 hours)
Time to target	Time from needle entering the skin until the needle is at the target	Immediately following intervention (within 2 hours)
Success of needle placement	A confirmatory CT will be performed to check if the needle reached the target	Immediately following intervention (within 2 hours)

Collaborators and Investigators

• Sponsor: Clear Guide Medical
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Brian Holly, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Anticipated): June 22, 2018
• Study Completion (Anticipated): June 22, 2018

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; CT; Needle Guidance; Computer Assisted Instrument Guidance (CAIG); Ultrasound-CT Fusion; Image Fusion; Clear Guide SCENERGY; Needle path
• Other Study ID Numbers: CGM 17-001

Drug and device information, study documents

• 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