Medical DeviceNCT00732628
Evaluating Outcomes in the Placement of Boomerang Percutaneous Device
An observational study of Medical Device and Angiography, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the Boomerang percutaneous closure device following diagnostic cerebral angiography or neurointerventional procedures. Background: Very few publications have evaluated this relatively novel percutaneous closure device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Device, Angiography
- What is being tested?
- Boomerang closure device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2008
- 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 having a neurointerventional procedure, such as a cerebral angiography
Who may be able to join
- Any patient that has a percutaneous Boomerang closure device placed after having a neuro-intervention
Who cannot join
- Patients that do not have this medical device used post procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technical and Clinical Outcomes Following Placement of Boomerang Percutaneous Closure Device After Cerebral Angiography or Neurointerventional Procedures
The purpose of this study is to evaluate the safety and effectiveness of the Boomerang percutaneous closure device following diagnostic cerebral angiography or neurointerventional procedures.
Background:
Very few publications have evaluated this relatively novel percutaneous closure device.
Read the detailed description
The purpose of this study is to document our experiences using the Boomerang closure device. Several different closure devices are used in the department of Radiology. A closure device is something that is placed in the artery in the leg just prior to removing the catheters from your leg at the end of the imaging or treatment procedure that is to be performed in the Department of Radiology. The devices used are all FDA approved. This study will compare the Boomerang device (a newer FDA approved device) to the other older devices currently being used. You may not have the Boomerang device used in your procedure; however, the Boomerang device is used in almost all of our patients undergoing a neuro imaging or treatment procedure. The neuroradiologist will determine which device if any is best for you based on the size of your artery, your medical condition etc. We will only collect data about you and your procedure if the Boomerang device is used.
- Conditions
- Medical Device, Angiography
- Being tested
- Boomerang closure device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boomerang closure deviceDevice
Use of percutaneous of Boomerang closure device. Follow up outcomes evaluated after the use of Boomerang closure device.
| Study group | Role | What they receive |
|---|---|---|
| Boomerang percutaneous closure unit | patients having a Boomerang percutaneous closure device after a Neurointerventional study Receives: Device: Boomerang closure device |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startJan 2008
- Study completionSep 2008
Why it stopped: Physician is no longer associated with the Univ. of Michigan Medical Center
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical DeviceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732628
- Sponsor's protocol ID
- HUM13883
- Status last verified
- Feb 2009
- First submitted
- 25 Jul 2008
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical and Clinical Outcomes Following Placement of Boomerang Percutaneous Closure Device After Cerebral Angiography or Neurointerventional Procedures
- ClinicalTrials.gov ID
- NCT00732628
- Acronym / sponsor ID
- HUM13883
- Conditions
- Medical Device, Angiography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Physician is no longer associated with the Univ. of Michigan Medical Center
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2008
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Aug 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.
The purpose of this study is to evaluate the safety and effectiveness of the Boomerang percutaneous closure device following diagnostic cerebral angiography or neurointerventional procedures.
Background:
Very few publications have evaluated this relatively novel percutaneous closure device.
Detailed description
The purpose of this study is to document our experiences using the Boomerang closure device. Several different closure devices are used in the department of Radiology. A closure device is something that is placed in the artery in the leg just prior to removing the catheters from your leg at the end of the imaging or treatment procedure that is to be performed in the Department of Radiology. The devices used are all FDA approved. This study will compare the Boomerang device (a newer FDA approved device) to the other older devices currently being used. You may not have the Boomerang device used in your procedure; however, the Boomerang device is used in almost all of our patients undergoing a neuro imaging or treatment procedure. The neuroradiologist will determine which device if any is best for you based on the size of your artery, your medical condition etc. We will only collect data about you and your procedure if the Boomerang device is used.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boomerang percutaneous closure unit | – | Device: Boomerang closure devicepatients having a Boomerang percutaneous closure device after a Neurointerventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having a neurointerventional procedure, such as a cerebral angiography
Key inclusion criteria (1 listed)
- Any patient that has a percutaneous Boomerang closure device placed after having a neuro-intervention
Key exclusion criteria (1 listed)
- Patients that do not have this medical device used post procedure
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 |
|---|---|---|
| Boomerang closure deviceUse of percutaneous of Boomerang closure device. Follow up outcomes evaluated after the use of Boomerang closure device. | Device | Boomerang percutaneous closure unit |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Physician is no longer associated with the Univ. of Michigan Medical Center). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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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.
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 Medical Device and Angiography, run by University of Michigan 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 1 inclusion and 1 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 24 Feb 2009. 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: Physician is no longer associated with the Univ. of Michigan Medical Center). 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.
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 24 Feb 2009.