Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT01173133
Status:
UNKNOWN
Last Update Posted:
2011-02-01
First Post:
2010-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-06-30', 'releaseDate': '2016-05-23'}], 'estimatedResultsFirstSubmitDate': '2016-05-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-30', 'studyFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2010-07-29', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flap Failure and Compromise by Tissue Saturation Values (Efficacy)', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Oximetric Diagnosis compared to Clinical Diagnosis, Doppler', 'timeFrame': '72 hours'}, {'measure': 'Device Safety Measures (safety)', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Free Flap', 'Surgery', 'Ischemia', 'Outcome', 'Reconstructive Plastic Surgery', 'Monitoring'], 'conditions': ['Ischemia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to understand the relevance of tissue oximetry measures of tissue flaps during surgery and during recovery, and to determine if T-Stat is a reliable and early method of detecting compromised flaps.', 'detailedDescription': 'The tissue saturation of free flaps will be measured before, during, and after surgery and during recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgical breast reconstruction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Under surgical breast reconstruction\n* Informed consent\n\nExclusion Criteria:\n\n* Failure to give consent'}, 'identificationModule': {'nctId': 'NCT01173133', 'briefTitle': 'Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectros Corporation'}, 'officialTitle': 'Skin Flap Visible Light Spectroscopy (VLS) Oximetry for Monitoring Free-Flap Ischemia During Breast Reconstruction and Recovery', 'orgStudyIdInfo': {'id': 'FLA-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '94010-3282', 'city': 'Burlingame', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Griffin, MD', 'role': 'CONTACT', 'phone': '650-348-1503'}, {'name': 'John Griffin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mills Penisula Hospital', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}], 'centralContacts': [{'name': 'John Griffin, MD', 'role': 'CONTACT', 'phone': '650-348-1503'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spectros Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mills-Peninsula Medical Center', 'class': 'UNKNOWN'}, {'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Clinical Coordinator', 'oldOrganization': 'Spectros Corporation'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-05-23', 'type': 'RELEASE'}, {'date': '2016-06-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'David Benaron, CEO, Spectros Corporation'}}}}