Image Guidance for Improved Vessel Cannulation in Pediatr... | NCT04031495

Studies
Image Guidance for Improved Vessel Cannulation in Pediatric Patients

NCT04031495

Sponsor

Clear Guide Medical

Status

Completed

Last Update Posted

Jul 24, 2019Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Central Vein Cannulation

Interventions

central vein cannulation

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 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2019Actual

Primary Completion Date

May 10, 2019Actual

Completion Date

May 10, 2019Actual

First Submitted Date

Apr 17, 2019

First Submission Date that Met QC Criteria

Jul 22, 2019

First Posted Date

Jul 24, 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

Jul 22, 2019

Last Update Posted Date

Jul 24, 2019Actual

Name	Class
Children's National Research Institute	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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios.

Detailed Description

Phase I Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios. n=5 patients will be enrolled, and success would be 4 children (80%) successfully cannulated with a single pass using the P-SCENERGY.

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

4Actual

Name	Type	Description	Arm Group Labels	Other Names
central vein cannulation	Device	central vein cannulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful Central Vein Cannulation	device enabled successful cannulation on the first pass showing feasibility to aid in cvcs	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric patients of weight between 5 and 25 kg requiring a central vein cannulation

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karun Sharma, MD	Children's National Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Medical Center		Washington D.C.	District of Columbia	20910	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

Type	Date	Date Unknown
Release	Jul 26, 2019
Reset	Aug 13, 2019

Submission Tracking

Estimated Results First Submitted Date

Jul 26, 2019

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 26, 2019			Aug 13, 2019
Jul 2, 2026