Ultrasound-CT Fusion System for Interventional Radiology Procedures

NCT03226535 | Unknown FDA Device

• 1 other identifier: CGM 17-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Computer Assisted Instrument Guidance (CAIG); Ultrasound-CT Fusion; Image Fusion; Clear Guide SCENERGY; Needle path; Needle Guidance; CT; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Number of CT scans or CT fluoroscopic images

  Immediately following intervention (within 2 hours)

Secondary Outcomes (3)

• Total procedure time

  Immediately following intervention (within 2 hours)

• Time to target

  Immediately following intervention (within 2 hours)

• Success of needle placement

  Immediately following intervention (within 2 hours)

Study Arms (2)

Ultrasound-CT Fusion Guidance

EXPERIMENTAL

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

Device: Ultrasound-CT Fusion

CT Guidance

NO INTERVENTION

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

Interventions

Ultrasound-CT Fusion 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.

Also known as: Clear Guide SCENERGY

Ultrasound-CT Fusion Guidance

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent
• Prisoners, pregnant women, and children

Sponsors & Collaborators

• Clear Guide Medical: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Study Officials

• Brian Holly, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Holly, MD

CONTACT

410-614-1622; bholly3@jhmi.edu

Taylor Dunklin, DA

CONTACT

410-502-5118; tdunkli1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: June 22, 2017
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)