Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00671203
NCT00671203CompletedPhase 3

Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair

Spectros Corporation4 sites in 1 country500 target enrollmentStarted: June 1, 2007Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
500
Locations
4
Primary Endpoint
Detect colon ischemia early
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
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

Outcomes

Primary Outcomes

Detect colon ischemia early

Time Frame: Just before, and during, surgery or stenting

Secondary Outcomes

  • Allows change in the untreated course of colon ischemia(28 days or discharge from hospital)

Investigators

Sponsor
Spectros Corporation
Sponsor Class
Industry

Study Sites (4)

Loading locations...

Similar Trials

Completed
Not Applicable
Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm RepairAbdominal Aortic Aneurysm
NCT03429647University Hospital, Basel, Switzerland20
Completed
Not Applicable
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study.abdominal aortic widening1000318410002363abdominal aortic aneurysm
NL-OMON54411Shape Memory Medical15
Active, not recruiting
Not Applicable
ääkehoito aorttaläpän stenoosin ehkäisyssäAngiotensiinireseptorin salpaajan vaikutukset stenoottisen aorttaläpän tulehdukseen, fibroosiin ja kalkkiutumiseeAorttaläpän stenoosiMedDRA version: 9.1Level: LLTClassification code 10002918Term: Aortic valve stenosis
EUCTR2007-003162-17-FIMarkku Kupari
Completed
Not Applicable
Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk PatientsIliac AneurysmInternal Iliac AneurysmAbdominal Aortic Aneurysm
NCT00583414The Cleveland Clinic401
Terminated
Not Applicable
Effects of Ischemic Preconditioning After Aortic ClampingVascular SurgeryIschemia-reperfusionIschemia Preconditioning
NCT02254642University Hospital, Strasbourg, France59