Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Information source: Spectros Corporation
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colon Ischemia; Aortic Aneurysm
Intervention: Reestablish colon blood flow (Procedure)
Phase: Phase 3
Status: Recruiting
Sponsored by: Spectros Corporation Overall contact:
Eugene Lee, MD, Phone: 916-734-2011, Email: eugenes.lee@ucdmc.ucdavis.edu
Summary
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.
Clinical Details
Official title: Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Detect colon ischemia early
Secondary outcome: Allows change in the untreated course of colon ischemia
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Aortic Aneurysm, intact or ruptured
- Repair by catheter based stent or by open surgery during monitoring
- Patent rectum
- Absence of rectal bleeding
Exclusion Criteria:
- Lack of informed consent
- Rectal bleeding
- Obstructed rectum
Locations and Contacts
Eugene Lee, MD, Phone: 916-734-2011, Email: eugenes.lee@ucdmc.ucdavis.edu
Stanford University Vascular Surgery, Palo Alto, California 94305, United States; Recruiting
Jason Lee, MD, Phone: 650-723-4000, Email: jtlee@stanford.edu
University of California at Davis Medical Center, Davis, California 95817, United States; Recruiting
Christy Pifer, RN, Phone: 916-734-4156, Email: christy.pifer@ucdmc.ucdavis.edu
Additional Information
Spectros Corporation T-Stat Web Site
Related publications: 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. Epub 2006 Sep 20. 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.
Starting date: June 2007
Last updated: February 5, 2009
|
