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Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Information source: Spectros Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colon Ischemia; Aortic Aneurysm

Intervention: Reestablish colon blood flow (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Spectros Corporation


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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Detect colon ischemia early

Secondary outcome: Allows change in the untreated course of colon ischemia


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

University of California at Davis Medical Center, Davis, California 95817, United States

Stanford University Vascular Surgery, Palo Alto, California 94305, United States

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: January 30, 2011

Page last updated: August 23, 2015

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