search
Back to results

Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters

Primary Purpose

Septicemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Initial Specimen Diversion Device (ISDD)
Lab standard practice (LSP)
Peripheral Intravenous Catheters (PIVC)
Sponsored by
Magnolia Medical Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Septicemia focused on measuring Septicemia, Blood culture, Contamination

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults >19 years old

Exclusion Criteria:

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Initial Specimen Diversion Device (ISDD)

Lab standard practice (LSP)

Arm Description

The ISDD will be used to collect the blood culture.

The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized.

Outcomes

Primary Outcome Measures

Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC

Secondary Outcome Measures

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.

Full Information

First Posted
March 17, 2014
Last Updated
August 9, 2017
Sponsor
Magnolia Medical Technologies, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02093494
Brief Title
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters
Official Title
A Randomized, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination Compared to Laboratory Standard Procedures When Collected Through Peripheral Intravenous Catheters (PIVC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Magnolia Medical Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septicemia
Keywords
Septicemia, Blood culture, Contamination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial Specimen Diversion Device (ISDD)
Arm Type
Experimental
Arm Description
The ISDD will be used to collect the blood culture.
Arm Title
Lab standard practice (LSP)
Arm Type
Active Comparator
Arm Description
The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized.
Intervention Type
Device
Intervention Name(s)
Initial Specimen Diversion Device (ISDD)
Intervention Type
Procedure
Intervention Name(s)
Lab standard practice (LSP)
Intervention Type
Device
Intervention Name(s)
Peripheral Intravenous Catheters (PIVC)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evaluate the occurrence of any adverse device effects
Description
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
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults >19 years old Exclusion Criteria: Not a good candidates for direct-to-media (DTM) technique
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Patton, M.D.
Organizational Affiliation
Magnolia Medical Technologies, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters

We'll reach out to this number within 24 hrs