Ultrasound-CT Fusion System for Interventional Radiology Procedures

NCT ID: NCT03226535

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-22
• Study Completion Date: 2018-06-22

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ultrasound-CT Fusion Guidance

The participants in this group (test group) will utilize the ultrasound-CT fusion system for guiding needle placement.

Group Type: EXPERIMENTAL

Ultrasound-CT Fusion

Intervention Type: DEVICE

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.

CT Guidance

The participants in this group (control group) will receive the procedure with traditional CT methods and equipment, for guiding needle placement.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Clear Guide SCENERGY

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

• Prisoners, pregnant women, and children

Exclusion Criteria

• Unable to give informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Clear Guide Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Holly, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brian Holly, MD

Role: CONTACT

bholly3@jhmi.edu

410-614-1622

Taylor Dunklin, DA

Role: CONTACT

tdunkli1@jhmi.edu

410-502-5118

Facility Contacts

Brian Holly, MD

Role: primary

bholly3@jhmi.edu

410-614-1622

Taylor Dunklin, DA

Role: backup

tdunkli1@jhmi.edu

410-502-5118

Other Identifiers

CGM 17-001

Identifier Type: -

Identifier Source: org_study_id