Evaluation of Accuvein in Obese Patients | NCT02015845

Studies
Evaluation of Accuvein in Obese Patients

NCT02015845

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

May 19, 2017Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Primary Care

Interventions

Accuvein
Routine technique

Countries

France

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

ID	Type	Description	Link
2013-A00777-38	Other Identifier	ANSM

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recrutment difficulties

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Dec 5, 2013

First Submission Date that Met QC Criteria

Dec 13, 2013

First Posted Date

Dec 19, 2013Estimated

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

May 18, 2017

Last Update Posted Date

May 19, 2017Actual

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 evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.

Detailed Description

Not provided

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

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Accuvein	Experimental	Use of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients	Device: Accuvein
Routine technique	Active Comparator	Routine technique used to insert a peripheral intravenous catheters in obese patients.	Device: Routine technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Accuvein	Device		Accuvein
Routine technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of success of the first vein puncture	Successful successful placement of IV catheter	one hour

Secondary Outcomes

Measure	Description	Time Frame
Score of evaluation of the device	Evaluation of the device by the operator and the patient	one hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obese adults ( BMI equal or greater 35) requiring a venous blood sampling or the placement of a venous peripheral catheter

Exclusion Criteria:

pregnant woman

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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
Institut Hospitalier Franco-Britannique		Levallois-Perret	Hauts de Seine	92300	France