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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01020461
Other study ID # 2009/43
Secondary ID
Status Terminated
Phase Phase 4
First received November 22, 2009
Last updated September 22, 2016
Start date January 2010
Est. completion date April 2013

Study information

Verified date September 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. 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, decreases the number of sticks, and decreases the patient's perception of the pain.


Recruitment information / eligibility

Status Terminated
Enrollment 522
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults requiring a venous blood sampling or the placement of a venous peripheral catheter

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Accuvein
Accuvein will be used to facilitate venous blood sampling
Accuvein
Accuvein will be used to facilitate peripheral IV catheter placement

Locations

Country Name City State
France Hôpital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to successful blood sampling or to successful placement of IV catheter one hour No
Secondary Number of attempts required Immediately after attempts No
Secondary Pain Immediately after attempts No
Secondary Increases in the ease and efficiency of venous cannulation perceived by the operator) Immediately after attempts No
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