An interventional study of Initial Specimen Diversion Device (ISDD) and Lab standard practice (LSP) in Septicemia, sponsored by Magnolia Medical Technologies, Inc.. Terminated at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-08-11.
Sponsored by Magnolia Medical Technologies, Inc. · Not applicable, Interventional, and Diagnostic
This is a randomized, 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 PIVC's 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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 200 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Magnolia Medical Technologies, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The ISDD will be used to collect the blood culture.
Device: Initial Specimen Diversion Device (ISDD)
The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized.
Procedure: Lab standard practice (LSP) · Device: Peripheral Intravenous Catheters (PIVC)
Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC
Time frame: Baseline
Evaluate the occurrence of any adverse device effects
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. Any issues with the function of the device will be reported by the phlebotomist on a device incident form. The sponsor will maintain these reports in a database. As this is a commercially available device, medical device reporting shall be performed in accordance with 21 CFR 803, as applicable.
Time frame: Baseline
Evaluate the contamination rates, taking into account the confounding effects of blood draw setting and departure from direct-to-media (DTM) technique
Time frame: Baseline
This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Magnolia Medical Technologies, Inc.