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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02093494
Other study ID # MMT1303
Secondary ID
Status Terminated
Phase N/A
First received March 17, 2014
Last updated August 9, 2017
Start date January 2014
Est. completion date May 2015

Study information

Verified date August 2017
Source Magnolia Medical Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 200
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Adults >19 years old

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Initial Specimen Diversion Device (ISDD)

Procedure:
Lab standard practice (LSP)

Device:
Peripheral Intravenous Catheters (PIVC)


Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Magnolia Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Evaluate the contamination rates, taking into account the confounding effects of blood draw setting and departure from direct-to-media (DTM) technique Baseline
Primary Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC Baseline
Secondary 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. Baseline
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