Novel Guidance Device for Image Fusion and Needle Guidanc... | NCT04039529

Studies
Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy

NCT04039529

Sponsor

Clear Guide Medical

Status

Withdrawn

Last Update Posted

Feb 9, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Liver Biopsy
Lung Biopsy
Kidney Biopsy

Interventions

SCENERGY-guided Biopsy

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

covid pandemic

Expanded Access Info

Start Date

Dec 31, 2019Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 29, 2019

First Submission Date that Met QC Criteria

Jul 30, 2019

First Posted Date

Jul 31, 2019Actual

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

Feb 7, 2023

Last Update Posted Date

Feb 9, 2023Actual

Name	Class
Temple University	OTHER
National Institutes of Health (NIH)	NIH

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

This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.

Detailed Description

This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CT-only guided biopsy	No Intervention	The current standard of care for biopsy at Temple University Hospital.
SCENERGY-guided Biopsy	Experimental	The use of the SCENERGY to fuse CT and Ultrasound for biopsy	Device: SCENERGY-guided Biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SCENERGY-guided Biopsy	Device	Use of SCENERGY during a lung, liver or kidney biopsy	SCENERGY-guided Biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiation Dose during Procedure	The number of CTs or Fluoroscopy shots during the biopsy	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Time to Reach Target of Biopsy	The amount of time in seconds that the physician takes to reach the target of biopsy	1 hour
Experience Level	Number of years physician has practiced in Interventional Radiology

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy.

Exclusion Criteria:

any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Temple University Hospital		Philadelphia	Pennsylvania	19140	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided