A Comprehensive Look at Vascular Access | NCT01638065

Studies
A Comprehensive Look at Vascular Access

NCT01638065

Sponsor

Christie Medical Holdings, Inc.

Status

Completed

Last Update Posted

Feb 3, 2014Estimated

Enrollment

196Actual

Phase

Not provided

Conditions

Vascular Access

Interventions

Not provided

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

Jan 2014

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

May 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jul 9, 2012

First Submission Date that Met QC Criteria

Jul 10, 2012

First Posted Date

Jul 11, 2012Estimated

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

Jan 30, 2014

Last Update Posted Date

Feb 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

196Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard		Standard IV Access without device
VeinViewer		IV access with VeinViewer device

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint will be total number of attempts for successful cannulation.		1 day

Secondary Outcomes

Measure	Description	Time Frame
Amount of time for successful venous access		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Requires peripheral venous access
Intact skin on areas of assessment
Patient and/or parent or legal guardian is able to understand consent

Exclusion Criteria:

No Intact skin
Patient is under anesthesia during peripheral venous access
Patient is not a suitable candidate, as determined by the discretion of the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients at a medical facility requiring IV access.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LA County Hospital		Los Angeles	California	90033	United States
Good Samaritan Hospital