Ultrasound-CT Fusion System for Interventional Radiology Procedures

CT Guided Biopsy Clinical Trial

Official title:

Ultrasound-CT Fusion System for Interventional Radiology Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03226535
• Other study ID #: CGM 17-001
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2017
• Last updated: July 20, 2017
• Start date: June 22, 2017
• Est. completion date: June 22, 2018

Study information

• Verified date: July 2017
• Source: Clear Guide Medical
• Contact: Brian Holly, MD
• Phone: 410-614-1622
• Email: bholly3[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 22, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Clear Guide Medical	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CT scans or CT fluoroscopic images		Immediately following intervention (within 2 hours)
Secondary	Total procedure time	Time from the first CT scan until the needle is at the target	Immediately following intervention (within 2 hours)
Secondary	Time to target	Time from needle entering the skin until the needle is at the target	Immediately following intervention (within 2 hours)
Secondary	Success of needle placement	A confirmatory CT will be performed to check if the needle reached the target	Immediately following intervention (within 2 hours)