Cerebral AneurysmOCTNCT00556309
Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.
An observational study of Cerebral Aneurysm, run by University of California, Irvine at 2 sites in United States.
Trial summary
The purpose of this study is to identify the healing of aneurysms in three month use Optical Coherence Tomography image to measure outcomes in post coiled aneurysms. Endovascular therapeutic coiling is a widely used procedure in the management of aneurysms, which is an angiogram . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to May 2011
- 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: Primary care clinic
Who may be able to join
- Age ≥ 18 years of age
- Subject diagnosis of aneurysm and undergoing endovascular coiling
Who cannot join
- Pregnant women
- Age ≤ 18 years of age
- Patient presenting emergently with acutely ruptured aneurysms
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beckman Laser Institute,University of California, Irvine
Irvine, California, 92612
Neurosurgery department, University of California,Irvine
Irvine, California, 92612
About this study
The purpose of this study is to identify the healing of aneurysms in three month use Optical Coherence Tomography image to measure outcomes in post coiled aneurysms. Endovascular therapeutic coiling is a widely used procedure in the management of aneurysms, which is an angiogram .
Read the detailed description
Subarachnoid hemorrhage secondary to ruptured cerebral aneurysms, unruptured aneurysms that are being treated using endovascular coiling. The researcher can use Optical Coherence Tomography image at the rime of initial angiography with unruptured aneurysms, and at the three month follow up catheter angiogram.
Optical Coherence Tomography image can follow the therapeutic coiling of the aneurysm, the 6F endocatheter and the microcatheter used for the coiling procedure place in the internal carotid artery and parent artery lumen follow with Optical Coherence Tomography fiber insert through the lumen of the tube on which the image can obtain.
- Conditions
- Cerebral Aneurysm
- Being tested
- Optical Coherence Tomography
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDevice
Also called Optical Coherence Tomography Imaging
Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Tool | Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing. Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm Healing
Optical Coherence Tomography Imaging
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Marlon Mathew, MD, Principal investigator, UCIMCZhongping Chen, PhD, Principal investigator, Zhongping Chen, PhD, Assistant Professor, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556309
- Sponsor's protocol ID
- 20065031
- Acronym
- OCT
- Status last verified
- Oct 2022
- First submitted
- 7 Nov 2007
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Imaging of Post Coil Aneurysm Healing.
- ClinicalTrials.gov ID
- NCT00556309
- Acronym / sponsor ID
- OCT / 20065031
- Conditions
- Cerebral Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Jan 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Nov 2007 (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 purpose of this study is to identify the healing of aneurysms in three month use Optical Coherence Tomography image to measure outcomes in post coiled aneurysms. Endovascular therapeutic coiling is a widely used procedure in the management of aneurysms, which is an angiogram .
Detailed description
Subarachnoid hemorrhage secondary to ruptured cerebral aneurysms, unruptured aneurysms that are being treated using endovascular coiling. The researcher can use Optical Coherence Tomography image at the rime of initial angiography with unruptured aneurysms, and at the three month follow up catheter angiogram.
Optical Coherence Tomography image can follow the therapeutic coiling of the aneurysm, the 6F endocatheter and the microcatheter used for the coiling procedure place in the internal carotid artery and parent artery lumen follow with Optical Coherence Tomography fiber insert through the lumen of the tube on which the image can obtain.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Tool | – | Device: Optical Coherence TomographyOptical Coherence Tomography Imaging of Post Coil Aneurysm Healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Age ≥ 18 years of age
- Subject diagnosis of aneurysm and undergoing endovascular coiling
Key exclusion criteria (3 listed)
- Pregnant women
- Age ≤ 18 years of age
- Patient presenting emergently with acutely ruptured aneurysms
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 |
|---|---|---|
| Optical Coherence TomographyAlso: Optical Coherence Tomography ImagingOptical Coherence Tomography Imaging of Post Coil Aneurysm Healing. | Device | Diagnostic Tool |
Primary outcome
Aneurysm Healing
Time frame: up to 12 months
Optical Coherence Tomography Imaging
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 20 Oct 2022.
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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.
Marlon Mathew, MD principal investigator
UCIMC
Zhongping Chen, PhD principal investigator
Zhongping Chen, PhD, Assistant Professor, Beckman Laser Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Aneurysm, run by University of California, Irvine 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 2 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 20 Oct 2022. 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.
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?
Aneurysm Healing (time frame: up to 12 months). 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 20 Oct 2022.