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Real-Time VLS Detection of Colon Ischemia in AAA Repair

Real-Time VLS Detection of Colon Ischemia in AAA Repair
AAA 修复中结肠缺血的实时 VLS 检测
批准号：
7277202
负责人：
David A. Benaron
金额：
$55.87万
依托单位：
SPECTROS CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
项目状态：
已结题
起止时间：
2004-09-30 至 2009-07-31
来源：
https://reporter.nih.gov/project-details/7277202
关键词：
AbdomenAbdominal Aortic AneurysmAcuteAddressAdultAnesthesia proceduresAneurysmAortic AneurysmBlood VesselsCaliforniaCathetersCause of DeathCessation of lifeClinicalColonComplicationDeath RateDetectionDevicesEarly DiagnosisEnrollmentFinancial costGenus ColaGoalsGrantHospitalsHourHumanInfarctionInjuryInterventionIschemiaLeadLeftLifeMeasuresMesenteryMonitorMulticenter TrialsNumbersOperative Surgical ProceduresOutcomeOutcome MeasurePatientsPerfusionPhasePhase I Clinical TrialsPhase II Clinical TrialsPopulationPreventionPrincipal InvestigatorRateResearchRiskRuptureRuptured Abdominal Aortic AneurysmSafetySmall Business Funding MechanismsSmall Business Innovation Research GrantStandards of Weights and MeasuresSterilitySystemTechniquesTestingTimeUnited States Food and Drug AdministrationUnited States National Institutes of HealthVisible Radiationbiomaterial compatibilityclinical applicationclinical efficacycostdaydesignexperienceimprovedpilot trialpreventprogramsprospectiverectalrepairedsuccess

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DESCRIPTION (provided by applicant): We saved patient lives in Phase I, and met or exceed all Phase I milestones. We now propose to verify and extend these results in an expanded trial at 3 leading clinical centers (Stanford, Univ. of California, VA). This Phase II SBIR proposal addresses the need to detect colon ischemia associated with the repair of Abdominal Aortic Aneurysm (AAA), a lethal complication of AAA repair. An abdominal aneurysm is found in 5% of adults over 50, and its repair or rupture is the 13th leading cause of death in the U.S. A lethal complication of AAA repair is colon ischemia (1-2% rate of ischemia to the gut, confirmed in 2004 studies from NYU, SUNY, and DREAM study). Of those developing moderate to severe colon ischemia after AAA repair, the majority die before leaving the hospital of irreversible colon infarction. Early surgical intervention improves outcome ONLY if the ischemia is detected and treated within hours. Once the colon dies and the patientnitoring. In Phase I, we developed and tested a rectal probe to detect acute ischemia, and changed outcome. PHASE I RESULTS: PATIENTS w/ PROBE PATIENTS w/o PROBE Number of Patients in Phase I Study 38 Study Patients 526 Controls ICU Days (patients w/ischemia) 2 Days in ICU 29 Days in ICU (p<0.001) Death Rate (patients w/ischemia) 0% Died 55% Died The specific aims of this Phase II (R44) proposal are: (1) to manufacture a commercializable probe to FDA standards, (2) to extend the R43 study into a pivotal NIH-Phase Ill-Type multi-center trial of 500 patients undergoing AAA repair, validating the clinical efficacy of colon monitoring on 5 outcome measures. If successful, the probe will be commercialized. Spectros founders have already founded and taken other biotech firms public (Xenogen), and Spectros itself is selling an SBIR-supported product for anesthesia use.
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  • 财政年份：
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  • 批准号：
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