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| ID | Type | Description | Link |
|---|---|---|---|
| NIH DK068927 |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| University of California | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reestablish colon blood flow | Procedure | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Detect colon ischemia early | Just before, and during, surgery or stenting |
| Measure | Description | Time Frame |
|---|---|---|
| Allows change in the untreated course of colon ischemia | 28 days or discharge from hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Davis Medical Center | Davis | California | 95817 | United States | ||
| Stanford University Vascular Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17137857 | Background | 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. doi: 10.1016/j.gie.2006.05.007. Epub 2006 Sep 20. | |
| 15166566 | Background | 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. doi: 10.1097/00000542-200406000-00019. |
| Label | URL |
|---|---|
| Spectros Corporation T-Stat Web Site | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 23, 2016 | |
| Reset | Jun 30, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 23, 2016 | Jun 30, 2016 |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Palo Alto |
| California |
| 94305 |
| United States |
| 16978651 | Result | 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. doi: 10.1016/j.jss.2006.05.014. Epub 2006 Sep 15. |
| 18295116 | Result | 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. doi: 10.1016/j.jvs.2007.09.037. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |