Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement

This study has been completed.
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
First received: March 19, 2011
Last updated: April 19, 2016
Last verified: April 2016
The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.

Condition Intervention
Device: Masimo Pronto 7

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of the Hemoglobin Results Obtained With the Masimo Pronto 7 and the Clinical Laboratory Measurement Study

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • accuracy of Masimo Pronto 7 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    correlation, Bland and Altman analysis

Estimated Enrollment: 300
Study Start Date: January 2011
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Masimo Pronto 7
    non invasive hemoglobin determination by the Masimo Pronto 7 versus laboratory hemoglobin measurement

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01321580

Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Fischler, Hopital Foch
ClinicalTrials.gov Identifier: NCT01321580     History of Changes
Other Study ID Numbers: 2010/43 
Study First Received: March 19, 2011
Last Updated: April 19, 2016
Health Authority: France: Direction Générale de la Santé

ClinicalTrials.gov processed this record on May 01, 2016