Working… Menu
Trial record 57 of 180 for:    ERYTHROMYCIN

Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671203
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : February 1, 2011
Stanford University
University of California
Information provided by:
Spectros Corporation

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.

Condition or disease Intervention/treatment Phase
Colon Ischemia Aortic Aneurysm Procedure: Reestablish colon blood flow Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Study Start Date : June 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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)

Primary Outcome Measures :
  1. Detect colon ischemia early [ Time Frame: Just before, and during, surgery or stenting ]

Secondary Outcome Measures :
  1. Allows change in the untreated course of colon ischemia [ Time Frame: 28 days or discharge from hospital ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671203

Layout table for location information
United States, California
University of California at Davis Medical Center
Davis, California, United States, 95817
Stanford University Vascular Surgery
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Spectros Corporation
Stanford University
University of California

Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Spectros Corporation, Clinical Studies Director Identifier: NCT00671203     History of Changes
Other Study ID Numbers: AAA-002
NIH DK068927
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011
Keywords provided by Spectros Corporation:
Tissue oximetry
Aortic Aneurysm Repair
Aortic Stent
Vascular Stent
Aortic graft
Vascular graft
Additional relevant MeSH terms:
Layout table for MeSH terms
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Aortic Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action