Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

January 30, 2011 updated 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Reestablish colon blood flow

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Davis, California, United States, 95817
    - University of California at Davis Medical Center
  - Palo Alto, California, United States, 94305
    - Stanford University Vascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detect colon ischemia early Time Frame: Just before, and during, surgery or stenting	Just before, and during, surgery or stenting

Secondary Outcome Measures

Outcome Measure	Time Frame
Allows change in the untreated course of colon ischemia Time Frame: 28 days or discharge from hospital	28 days or discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectros Corporation

Collaborators

Stanford University

University of California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Spectros Corporation T-Stat Web Site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 1, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 5, 2008

Study Record Updates

Last Update Posted (Estimate)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 30, 2011

Last Verified