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Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02102087
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):
Magnolia Medical Technologies, Inc.

Brief Summary:
This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.

Condition or disease Intervention/treatment Phase
Septicemia Device: Initial Specimen Diversion Device (ISDD) Device: Lab standard practice (LSP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 971 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Matched, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination When Compared to Laboratory Standard Procedures
Study Start Date : July 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Initial Specimen Diversion Device (ISDD)
The ISDD will be used in conjunction with standard blood culture bottles.
Device: Initial Specimen Diversion Device (ISDD)
Active Comparator: Lab standard practice (LSP)
A standard blood culture kit will be used.
Device: Lab standard practice (LSP)

Primary Outcome Measures :
  1. Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) [ Time Frame: Baseline ]
    Comparison of contamination for each clinical episode. The proportions of discordant contamination episodes will be compared between the Initial Specimen Diversion Device and Lab Standard Practice using McNemar's test.

Secondary Outcome Measures :
  1. Occurrence rate of adverse device effects [ Time Frame: Baseline ]
    As the device under study enhances the blood diversion procedure during blood culture collection, and is part of standard blood collection standards, adverse device effects are not expected as a result of use of this device, but shall be recorded consistent with the adverse event definitions found in 21 CFR 812. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults >19 years old

Exclusion Criteria:

  • Not a good candidate for direct-to-media (DTM) technique

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02102087

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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
Magnolia Medical Technologies, Inc.
Publications of Results:
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Responsible Party: Magnolia Medical Technologies, Inc. Identifier: NCT02102087    
Other Study ID Numbers: MMT1302
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes