Colon IschemiaPhase 3NCT00671203
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
A Phase 3 study testing Reestablish colon blood flow in people with Colon Ischemia and Aortic Aneurysm, run by Spectros Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colon Ischemia, Aortic Aneurysm
- What is being tested?
- Reestablish colon blood flow
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aortic Aneurysm, intact or ruptured
- Repair by catheter based stent or by open surgery during monitoring
- Patent rectum
- Absence of rectal bleeding
Who cannot join
- Lack of informed consent
- Rectal bleeding
- Obstructed rectum
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California at Davis Medical Center
Davis, California, 95817
Stanford University Vascular Surgery
Palo Alto, California, 94305
About this study
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.
- Conditions
- Colon Ischemia, Aortic Aneurysm
- Being tested
- Reestablish colon blood flow
- Keywords
- Tissue oximetry, Ischemia, Aortic Aneurysm Repair, Aortic Stent, Vascular Stent, Aortic graft, Vascular graft
- Medical subject headings
- Aortic Aneurysm, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reestablish colon blood flowProcedure or surgery
Also called T-Stat Ischemia Detection System (#303), T-Stat 5mm sensor catheter (#CTH-060)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect colon ischemia early
Measured: Just before, and during, surgery or stenting
Secondary outcomes (1)
Allows change in the untreated course of colon ischemia
Measured: 28 days or discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startJun 2007
- Primary completionSep 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, University of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671203
- Sponsor's protocol ID
- AAA-002
- Other IDs
- NIH DK068927
- Status last verified
- Jan 2011
- First submitted
- 1 May 2008
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17137857Benaron 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.
PubMed 15166566Lee 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.
PubMed 16978651Lee 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.
PubMed 18295116
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
- ClinicalTrials.gov ID
- NCT00671203
- Acronym / sponsor ID
- AAA-002
- Conditions
- Colon Ischemia, Aortic Aneurysm
- Keywords
- Tissue oximetry, Ischemia, Aortic Aneurysm Repair, Aortic Stent, Vascular Stent, Aortic graft, Vascular graft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Spectros CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University, University of California
- Study start
- Jun 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Aortic Aneurysm, intact or ruptured
- Repair by catheter based stent or by open surgery during monitoring
- Patent rectum
- Absence of rectal bleeding
Key exclusion criteria (3 listed)
- Lack of informed consent
- Rectal bleeding
- Obstructed rectum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reestablish colon blood flowAlso: T-Stat Ischemia Detection System (#303), T-Stat 5mm sensor catheter (#CTH-060)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. | Procedure or surgery | – |
Primary outcome
Detect colon ischemia early
Time frame: Just before, and during, surgery or stenting
1 secondary outcome
Allows change in the untreated course of colon ischemia
Time frame: 28 days or discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
- Background: PubMed 17137857Friedland 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.
- Background: PubMed 15166566Benaron 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.
- Results publication: PubMed 16978651Lee 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.
- Results publication: PubMed 18295116Lee 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.
- Spectros Corporation T-Stat Web SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reestablish colon blood flow in people with Colon Ischemia and Aortic Aneurysm, run by Spectros Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect colon ischemia early (time frame: Just before, and during, surgery or stenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00671203, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011.