Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-13 @ 7:48 AM
Study NCT ID:
NCT01559506
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2012-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'self@nimbicsystems.com', 'phone': '281-565-5715', 'title': 'Sean Self', 'organization': 'Nimbic Systems'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No Device', 'description': 'Subject does not receive ABS system', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Air Barrier System Device', 'description': 'Device is deployed adjacent to the surgery site and activated.\n\nAir Barrier System device: Device is deployed adjacent to the surgery site and activated.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CFU Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No Device', 'description': 'Subject does not receive ABS system'}, {'id': 'OG001', 'title': 'Air Barrier System Device', 'description': 'Device is deployed adjacent to the surgery site and activated.\n\nAir Barrier System device: Device is deployed adjacent to the surgery site and activated.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.05', 'groupId': 'OG000', 'lowerLimit': '2.45', 'upperLimit': '7.65'}, {'value': '1.55', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '2.01'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Surgical case CFU density will be determined at up to 1 month from completion of surgical cases', 'description': 'Colony-forming unit density at incision site (CFU/m3)', 'unitOfMeasure': 'CFU/m^3', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No Device', 'description': 'Subject does not receive ABS system'}, {'id': 'FG001', 'title': 'Air Barrier System Device', 'description': 'Device is deployed adjacent to the surgery site and activated.\n\nAir Barrier System device: Device is deployed adjacent to the surgery site and activated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No Device', 'description': 'Subject does not receive ABS system'}, {'id': 'BG001', 'title': 'Air Barrier System Device', 'description': 'Device is deployed adjacent to the surgery site and activated.\n\nAir Barrier System device: Device is deployed adjacent to the surgery site and activated.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2012-03-14', 'resultsFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-16', 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CFU Density', 'timeFrame': 'Surgical case CFU density will be determined at up to 1 month from completion of surgical cases', 'description': 'Colony-forming unit density at incision site (CFU/m3)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CFU', 'surgery site'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures', 'detailedDescription': 'The ABS is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne colony-forming units at the surgery site during posterior spinal procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing lumbar and cervical laminectomy with instrumentation.\n\nExclusion Criteria:\n\n* Active infection\n* Prior prosthesis infection'}, 'identificationModule': {'nctId': 'NCT01559506', 'briefTitle': 'Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nimbic Systems, LLC'}, 'officialTitle': 'ABS to Reduce Contamination in Spine Surgery', 'orgStudyIdInfo': {'id': 'ABS-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No device', 'description': 'Subject does not receive ABS system'}, {'type': 'EXPERIMENTAL', 'label': 'Air Barrier System device', 'description': 'Device is deployed adjacent to the surgery site and activated.', 'interventionNames': ['Device: Air Barrier System device']}], 'interventions': [{'name': 'Air Barrier System device', 'type': 'DEVICE', 'description': 'Device is deployed adjacent to the surgery site and activated.', 'armGroupLabels': ['Air Barrier System device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Rabih O Darouiche, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}, {'name': 'Sean Self', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nimbic Systems'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nimbic Systems, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}