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Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

NCT02102087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 971

Last updated 2017-08-11

No results posted yet for this study

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.

Conditions

  • Septicemia

Interventions

DEVICE

Initial Specimen Diversion Device (ISDD)

DEVICE

Lab standard practice (LSP)

Sponsors & Collaborators

  • Magnolia Medical Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102087 on ClinicalTrials.gov