Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

This study has been completed.

Sponsor:

Collaborators:

Stanford University

University of California

Information provided by:

Spectros Corporation

ClinicalTrials.gov Identifier:

NCT00671203

First received: May 1, 2008

Last updated: January 30, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 1, 2008
Last Updated Date	January 30, 2011
Start Date ^ICMJE	June 2007
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 2, 2008)	Detect colon ischemia early [ Time Frame: Just before, and during, surgery or stenting ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00671203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 2, 2008)	Allows change in the untreated course of colon ischemia [ Time Frame: 28 days or discharge from hospital ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Official Title ^ICMJE	Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Colon Ischemia Aortic Aneurysm
Intervention ^ICMJE	Procedure: Reestablish colon blood flow If ischemia is detected, and the detection in consistent with the physician's clinical view, blood flow to the colon is established using any of the known techniques that would be used had the diagnosis been made in the absence of T-Stat, which include changes in the deployment of stents and/or coils, reanastomosis, reimplantation, or stenting, of obstructed vessels, or other established techniques. Other Names: T-Stat Ischemia Detection System (#303) T-Stat 5mm sensor catheter (#CTH-060)
Study Arm (s)	Not Provided
Publications *	Lee ES, Bass A, Arko FR, Heikkinen M, Harris EJ, Zarins CK, van der Starre P, Olcott C. Intraoperative colon mucosal oxygen saturation during aortic surgery. J Surg Res. 2006 Nov;136(1):19-24. Epub 2006 Sep 15. Lee ES, Pevec WC, Link DP, Dawson DL. Use of T-Stat to predict colonic ischemia during and after endovascular aneurysm repair: a case report. J Vasc Surg. 2008 Mar;47(3):632-4. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	500
Completion Date	January 2011
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00671203
Other Study ID Numbers ^ICMJE	AAA-002, NIH DK068927
Has Data Monitoring Committee	Yes
Responsible Party	Spectros Corporation, Clinical Studies Director
Study Sponsor ^ICMJE	Spectros Corporation
Collaborators ^ICMJE	Stanford University University of California
Investigators ^ICMJE	Not Provided
Information Provided By	Spectros Corporation
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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