Recruiting

Ultrasound-CT FusionUltrasound-CT Fusion System for Interventional Radiology Procedures

Sponsor:

Clear Guide Medical

Code:

NCT03226535

Conditions

CT Guided Biopsy

CT Guided Drain Placement Within the Abdomen or Pelvis

CT Guided Injection of Muscle or Nerve Within the Pelvis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasound-CT Fusion

Study Details

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

Study ID

NCT03226535

Start date

Jun 22, 2017

Status verified date

Jul, 2017

Completion date

Jun 22, 2018

Anticipated

Primary completion date

Jun 22, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Ultrasound-CT Fusion Guidance

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

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.

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.

Primary outcome measure

Number of CT scans or CT fluoroscopic images [ Time Frame: Immediately following intervention (within 2 hours) ]

Central Contacts and Locations

Central contacts

Brian Holly, MD

410-614-1622 bholly3@jhmi.edu

Taylor Dunklin, DA

410-502-5118 tdunkli1@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Brian Holly, MD

410-614-1622 bholly3@jhmi.edu

Taylor Dunklin, DA

410-502-5118 tdunkli1@jhmi.edu

Principal Investigator:

Brian Holly, MD

More Information

Sponsor

Clear Guide Medical

Last update posted

Jul 21, 2017

Last verified

Jul, 2017

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clear Guide Medical on 2017-07-21.