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Sponsors and Collaborators: |
Spectros Corporation Stanford University University of California |
Information provided by: | Spectros Corporation |
ClinicalTrials.gov Identifier: | NCT00671203 |
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.
This purpose of this study is to establish how T-Stat can best be used to prevent deaths.
Condition | Intervention | Phase |
Colon Ischemia Aortic Aneurysm |
Procedure: Reestablish colon blood flow |
Phase III |
MedlinePlus related topics: | Aneurysms |
ChemIDplus related topics: | Erythromycin Erythromycin estolate Erythromycin ethylsuccinate Erythromycin Gluceptate Erythromycin stearate |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair |
Estimated Enrollment: | 500 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eugene Lee, MD | 916-734-2011 | eugenes.lee@ucdmc.ucdavis.edu |
Contact: Jason Lee, MD | 650-723-4000 | jtlee@stanford.edu |
United States, California | |||||
Stanford University Vascular Surgery | Recruiting | ||||
Palo Alto, California, United States, 94305 | |||||
Contact: Jason Lee, MD 650-723-4000 jtlee@stanford.edu | |||||
University of California at Davis Medical Center | Recruiting | ||||
Davis, California, United States, 95817 | |||||
Contact: Christy Pifer, RN 916-734-4156 christy.pifer@ucdmc.ucdavis.edu |
Spectros Corporation |
Stanford University |
University of California |
Spectros Corporation T-Stat Web Site 
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Responsible Party: | Clinical Studies Director ( Spectros Corporation ) |
Study ID Numbers: | AAA-002, NIH DK068927 |
First Received: | May 1, 2008 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00671203 |
Health Authority: | United States: Food and Drug Administration |
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