Ultrasound-CT Fusion System for Interventional Radiology... | NCT03226535

Studies
Ultrasound-CT Fusion System for Interventional Radiology Procedures

NCT03226535

Sponsor

Clear Guide Medical

Status

Unknown status

Last Update Posted

Jul 21, 2017Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

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

Interventions

Ultrasound-CT Fusion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2017Actual

Primary Completion Date

Jun 22, 2018Estimated

Completion Date

Jun 22, 2018Estimated

First Submitted Date

Jul 18, 2017

First Submission Date that Met QC Criteria

Jul 20, 2017

First Posted Date

Jul 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2017

Last Update Posted Date

Jul 21, 2017Actual

Name	Class
Johns Hopkins University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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 Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brian Holly, MD	Contact	410-614-1622		bholly3@jhmi.edu
Taylor Dunklin, DA	Contact	410-502-5118		tdunkli1@jhmi.edu

Overall Officials

Name	Affiliation	Role
Brian Holly, MD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Hospital	Recruiting	Baltimore	Maryland	21287	United States

Type	Date	Date Unknown
Release	Apr 17, 2019
Reset	May 6, 2019

Submission Tracking

Estimated Results First Submitted Date

Apr 17, 2019

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 17, 2019			May 6, 2019