Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-28 @ 4:32 PM
Study NCT ID:
NCT00671203
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2008-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
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': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004917', 'term': 'Erythromycin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-30', 'studyFirstSubmitDate': '2008-05-01', 'studyFirstSubmitQcDate': '2008-05-02', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detect colon ischemia early', 'timeFrame': 'Just before, and during, surgery or stenting'}], 'secondaryOutcomes': [{'measure': 'Allows change in the untreated course of colon ischemia', 'timeFrame': '28 days or discharge from hospital'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tissue oximetry', 'Ischemia', 'Aortic Aneurysm Repair', 'Aortic Stent', 'Vascular Stent', 'Aortic graft', 'Vascular graft'], 'conditions': ['Colon Ischemia', 'Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '17137857', 'type': 'BACKGROUND', 'citation': 'Friedland S, Benaron D, Coogan S, Sze DY, Soetikno R. Diagnosis of chronic mesenteric ischemia by visible light spectroscopy during endoscopy. Gastrointest Endosc. 2007 Feb;65(2):294-300. doi: 10.1016/j.gie.2006.05.007. Epub 2006 Sep 20.'}, {'pmid': '15166566', 'type': 'BACKGROUND', 'citation': 'Benaron DA, Parachikov IH, Friedland S, Soetikno R, Brock-Utne J, van der Starre PJ, Nezhat C, Terris MK, Maxim PG, Carson JJ, Razavi MK, Gladstone HB, Fincher EF, Hsu CP, Clark FL, Cheong WF, Duckworth JL, Stevenson DK. Continuous, noninvasive, and localized microvascular tissue oximetry using visible light spectroscopy. Anesthesiology. 2004 Jun;100(6):1469-75. doi: 10.1097/00000542-200406000-00019.'}, {'pmid': '16978651', 'type': 'RESULT', 'citation': 'Lee ES, Bass A, Arko FR, Heikkinen M, Harris EJ, Zarins CK, van der Starre P, Olcott C. Intraoperative colon mucosal oxygen saturation during aortic surgery. J Surg Res. 2006 Nov;136(1):19-24. doi: 10.1016/j.jss.2006.05.014. Epub 2006 Sep 15.'}, {'pmid': '18295116', 'type': 'RESULT', 'citation': 'Lee ES, Pevec WC, Link DP, Dawson DL. Use of T-Stat to predict colonic ischemia during and after endovascular aneurysm repair: a case report. J Vasc Surg. 2008 Mar;47(3):632-4. doi: 10.1016/j.jvs.2007.09.037.'}], 'seeAlsoLinks': [{'url': 'http://www.spectros.com', 'label': 'Spectros Corporation T-Stat Web Site'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm surgery and stenting, allowing the surgeon or interventional radiologist to take action quickly, while the colon ischemia is still treatable.\n\nThis purpose of this study is to establish how T-Stat can best be used to prevent deaths.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aortic Aneurysm, intact or ruptured\n* Repair by catheter based stent or by open surgery during monitoring\n* Patent rectum\n* Absence of rectal bleeding\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Rectal bleeding\n* Obstructed rectum'}, 'identificationModule': {'nctId': 'NCT00671203', 'briefTitle': 'Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectros Corporation'}, 'officialTitle': 'Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair', 'orgStudyIdInfo': {'id': 'AAA-002'}, 'secondaryIdInfos': [{'id': 'NIH DK068927'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Reestablish colon blood flow', 'type': 'PROCEDURE', 'otherNames': ['T-Stat Ischemia Detection System (#303)', 'T-Stat 5mm sensor catheter (#CTH-060)'], 'description': "If ischemia is detected, and the detection in consistent with the physician's clinical view, blood flow to the colon is established using any of the known techniques that would be used had the diagnosis been made in the absence of T-Stat, which include changes in the deployment of stents and/or coils, reanastomosis, reimplantation, or stenting, of obstructed vessels, or other established techniques."}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Davis Medical Center', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Vascular Surgery', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spectros Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'University of California', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Spectros Corporation', 'oldOrganization': 'Clinical Studies Director'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-05-23', 'type': 'RELEASE'}, {'date': '2016-06-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'David Benaron, CEO, Spectros Corporation'}}}}