Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT02093494
Status:
TERMINATED
Last Update Posted:
2017-08-11
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate the contamination rates, taking into account the confounding effects of blood draw setting and departure from direct-to-media (DTM) technique', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Evaluate the occurrence of any adverse device effects', 'timeFrame': 'Baseline', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Septicemia', 'Blood culture', 'Contamination'], 'conditions': ['Septicemia']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>19 years old\n\nExclusion Criteria:\n\n* Not a good candidates for direct-to-media (DTM) technique'}, 'identificationModule': {'nctId': 'NCT02093494', 'briefTitle': 'Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Magnolia Medical Technologies, Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'MMT1303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Initial Specimen Diversion Device (ISDD)', 'description': 'The ISDD will be used to collect the blood culture.', 'interventionNames': ['Device: Initial Specimen Diversion Device (ISDD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lab standard practice (LSP)', 'description': 'The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized.', 'interventionNames': ['Procedure: Lab standard practice (LSP)', 'Device: Peripheral Intravenous Catheters (PIVC)']}], 'interventions': [{'name': 'Initial Specimen Diversion Device (ISDD)', 'type': 'DEVICE', 'armGroupLabels': ['Initial Specimen Diversion Device (ISDD)']}, {'name': 'Lab standard practice (LSP)', 'type': 'PROCEDURE', 'armGroupLabels': ['Lab standard practice (LSP)']}, {'name': 'Peripheral Intravenous Catheters (PIVC)', 'type': 'DEVICE', 'armGroupLabels': ['Lab standard practice (LSP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Richard Patton, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Magnolia Medical Technologies, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magnolia Medical Technologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}