Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Completed · Phase 3
Conditions studied: Colon Ischemia, Aortic Aneurysm
In brief
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.
Key facts
- Study ID
- NCT00671203
- Run by
- Spectros Corporation
- People needed
- 500
- Starts
- 2007-06-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2011-02-01
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Aortic Aneurysm, intact or ruptured
- Repair by catheter based stent or by open surgery during monitoring
- Patent rectum
- Absence of rectal bleeding
You may not qualify if…
- Lack of informed consent
- Rectal bleeding
- Obstructed rectum
Where it is running
- University of California at Davis Medical Center — Davis, California, United States
- Stanford University Vascular Surgery — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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