NCT00671203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2007

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

3.3 years

First QC Date

May 1, 2008

Last Update Submit

January 30, 2011

Conditions

Colon IschemiaAortic Aneurysm

Keywords

Tissue oximetryIschemiaAortic Aneurysm RepairAortic StentVascular StentAortic graftVascular graft

Outcome Measures

Primary Outcomes (1)

  • Detect colon ischemia early

    Just before, and during, surgery or stenting

Secondary Outcomes (1)

  • Allows change in the untreated course of colon ischemia

    28 days or discharge from hospital

Interventions

Reestablish colon blood flowPROCEDURE

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.

Also known as: T-Stat Ischemia Detection System (#303), T-Stat 5mm sensor catheter (#CTH-060)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California at Davis Medical Center

Davis, California, 95817, United States

Location

Stanford University Vascular Surgery

Palo Alto, California, 94305, United States

Location

Related Publications (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. doi: 10.1016/j.gie.2006.05.007. Epub 2006 Sep 20.

    PMID: 17137857BACKGROUND

  • 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.

    PMID: 15166566BACKGROUND

  • 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.

    PMID: 16978651RESULT

  • 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.

    PMID: 18295116RESULT

Related Links

MeSH Terms

Conditions

Aortic AneurysmIschemia

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 5, 2008

Study Start

June 1, 2007

Primary Completion

September 1, 2010

Study Completion

January 1, 2011

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

US(2)