Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Sponsor

Spectros Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00671203

Collaborator

Stanford University (Other), University of California (Other)

500

Enrollment

Locations

Duration (Months)

250

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2007

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Outcome Measures

Primary Outcome Measures

Detect colon ischemia early [Just before, and during, surgery or stenting]

Secondary Outcome Measures

Allows change in the untreated course of colon ischemia [28 days or discharge from hospital]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at Davis Medical Center	Davis	California	United States	95817
2	Stanford University Vascular Surgery	Palo Alto	California	United States	94305