Carotid EndarterectomyCerOxNCT02102386
Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries
An observational study of Carotid Endarterectomy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes in cerebral blood flow and oximetry during CEA surgery. Procedures include: Screening: ECG, blood draw, neurological assessment, NIHSS study: CerOX and TCD clock during CEA procedure, data collection from the medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Endarterectomy
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo elective carotid endarterectomy at Barnes Jewish Hospital.
Who may be able to join
- To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:
- 1. Consenting patients over 18 years, undergoing elective carotid endarterectomy at Barnes Jewish Hospital.
Who cannot join
- To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:
- Emergency surgery
- National Institute of health Stroke Scale (NIHSS) score >=10
- Sub-cutaneous hematoma at the ipsilateral intended area of the CerOx probe location.
- Laceration or scalp injury at the ipsilateral intended area of the CerOx probe location which contraindicates placement of the adhesive on the skin.
- Patient with implants located in the intended area of the CerOx probe location.
Show all 9Show fewer
- Prisoners
- Non-consenting patient Or non-participating surgeon schedule of assessments and procedures
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes in cerebral blood flow and oximetry during CEA surgery.
Procedures include:
Screening:
ECG, blood draw, neurological assessment, NIHSS
study: CerOX and TCD clock during CEA procedure, data collection from the medical record/monitors, neurological assessment, NIHSS
30 day follow-up
- Conditions
- Carotid Endarterectomy
- Keywords
- elective, carotid endarterectomy surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CerOx | Patients will be monitored using the CerOx monitor. Probes will be attached bi-laterally in the OR to the forehead. |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes
compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes
Measured: up to 3 hours
Secondary outcomes (1)
to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.
to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.
Measured: up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Technical issues with the device under study. Sponsor terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid EndarterectomyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kangrga, Washington University School of Medicine
- Investigators
- Ivan Kangrga, MD, PhD, Principal investigator, Washington Univesity School of MedicineAndrea Vannucci, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102386
- Sponsor's protocol ID
- 201312041
- Acronym
- CerOx
- Status last verified
- Jan 2015
- First submitted
- 29 Mar 2014
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries
- ClinicalTrials.gov ID
- NCT02102386
- Acronym / sponsor ID
- CerOx / 201312041
- Conditions
- Carotid Endarterectomy
- Keywords
- elective, carotid endarterectomy surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Technical issues with the device under study. Sponsor terminated.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Apr 2014 (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.
The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes in cerebral blood flow and oximetry during CEA surgery.
Procedures include:
Screening:
ECG, blood draw, neurological assessment, NIHSS
study: CerOX and TCD clock during CEA procedure, data collection from the medical record/monitors, neurological assessment, NIHSS
30 day follow-up
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CerOx | – | –Patients will be monitored using the CerOx monitor. Probes will be attached bi-laterally in the OR to the forehead. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo elective carotid endarterectomy at Barnes Jewish Hospital.
Key inclusion criteria (2 listed)
- To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:
- 1. Consenting patients over 18 years, undergoing elective carotid endarterectomy at Barnes Jewish Hospital.
Key exclusion criteria (9 listed)
- To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:
- Emergency surgery
- National Institute of health Stroke Scale (NIHSS) score >=10
- Sub-cutaneous hematoma at the ipsilateral intended area of the CerOx probe location.
- Laceration or scalp injury at the ipsilateral intended area of the CerOx probe location which contraindicates placement of the adhesive on the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes
Time frame: up to 3 hours
compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes
1 secondary outcome
to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.
Time frame: up to 3 hours
Results and safety
The study was stopped early (reason given: Technical issues with the device under study. Sponsor terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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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.
Ivan Kangrga, MD, PhD principal investigator
Washington Univesity School of Medicine
Andrea Vannucci, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Endarterectomy, run by Washington University School of Medicine at 1 site 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: Technical issues with the device under study. Sponsor terminated.). Results are not available in the source record.
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?
compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes (time frame: up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2015.