Central Venous CatheterSecurAcathNCT00903539
Prospective SecurAcath Subcutaneous Securement Trial
An observational study of Central Venous Catheter, run by Interrad Medical at 4 sites in United States.
Trial summary
To prospectively monitor the safety and performance of the catheter securement device in subjects whose catheter is secured with the Interrad Medical SecureAcath device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter
- What is being tested?
- SecurAcath Securement System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 217 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2009to 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: Patients indicated to have a central catheter placed at a hospital or private practice clinic are included in the study population.
Who may be able to join
- Age 18 or older
- Requires an intravenous catheter to be placed
Who cannot join
- Inability to understand the study or a history of non-compliance with medical advice.
- Unwilling or unable to sign Informed Consent Form (ICF).
- Had a previous catheter placed in the same side within the last 3 months.
- Known central venous thrombosis or occlusion or stenosis on the side of the body to be used for the catheter.
- History of upper extremity venous thrombosis on the side of the body to be used for the catheter.
- Known hypercoagulable disorder.
Show all 12Show fewer
- Diffuse skin inflammatory condition or rashes on the side to be used for the catheter line.
- Peripheral chemotherapy therapy in the same side as that to be used for the catheter line within 3 months.
- Known hypersensitivity to nickel.
- Any infection associated with positive blood cultures that are still present after 48 hours of antibiotic therapy.
- Previous mastectomy or axillary lymph node dissection on the same side as catheter implant.
- Subjects on chronic or recurrent systemic steroid medications for 6 months or longer.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Albany Medical Center
Albany, New York, 12208
Great Basin Imaging
Carson City, Nevada, 89706
North Memorial Hospital - Minneapolis Radiology
Robbinsdale, Minnesota, 55422
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102
About this study
Official title: Prospective SecurAcath Subcutaneous Securement Clinical Trial
To prospectively monitor the safety and performance of the catheter securement device in subjects whose catheter is secured with the Interrad Medical SecureAcath device.
Read the detailed description
Peripherally inserted central catheters (PICCs) and Central Venous Catheter (CVC) are widely used to deliver fluids directly to the central venous system and can remain in place for as short as a few days to as long as months. One of the highest risks in the use of these catheters is infection, both local and systemic. Currently, these catheters are secured by either sutures or adhesive patches. Sutures can create additional potential entry points for bacteria whereas both sutures and adhesive securement patches hold the catheter hub to the skin resulting in increased difficulty cleaning around the catheter entry site. Furthermore, securing a catheter outside the skin away from the catheter entry point, as with sutures or adhesive securement patches may potentiate pistoning of the catheter which is also believed to possibly increase infection risks. A second risk of intravenous catheter use is dislodgement during normal use and site maintenance. These catheters are often manipulated multiple times a day for blood sampling or injection of fluids. During manipulation, the catheter can be dislodged thus requiring an unplanned replacement of the catheter.
Interrad Medical has developed a means to secure indwelling catheters using a small subcutaneous anchor. With this system, cleaning around the catheter entry site is made easier and can be more thorough. The system is also designed to minimize the risk of catheter dislodgement because once the anchor is deployed, the catheter remains secured. This may simplify dressing changes compared to adhesive devices such as Statlock, which requires the catheter be released from the device and therefore be unsecured during dressing changes.
The objective of this post-market study is to monitor the safety and performance of the SecurAcath when used to secure the catheter to the insertion site via a subcutaneous anchor. The data collected may provide insight for future enhancements to improve the safety and utility of the device. It also provides a means for an early warning of any identified safety issues, and allows physicians to share their experiences thereby improve the quality of care provided to the patients.
- Conditions
- Central Venous Catheter
- Being tested
- SecurAcath Securement System
- Keywords
- Peripherally Inserted Central Catheter, Central Venous Catheter, Intravenous Catheter, StatLock, Patients indicated to have an intravenous catheter placed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecurAcath Securement SystemDevice
Also called PICC securement system
Subcutaneous catheter securement system
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Securement Success: defined as the percent of devices implanted and explanted without malfunction or device related complications attributed to the subcutaneous securement system.
Measured: Timeframe is the length of time the patient has the catheter in place. Can vary depending on the indication for the catheter (anywhere from 48 hours post-procedure to 6 months or more).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startJan 2009
- 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 Central Venous CatheterStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Interrad Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903539
- Sponsor's protocol ID
- 1180-001
- Acronym
- SecurAcath
- Status last verified
- Jan 2012
- First submitted
- 14 May 2009
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective SecurAcath Subcutaneous Securement Clinical Trial
- ClinicalTrials.gov ID
- NCT00903539
- Acronym / sponsor ID
- SecurAcath / 1180-001
- Conditions
- Central Venous Catheter
- Keywords
- Peripherally Inserted Central Catheter, Central Venous Catheter, Intravenous Catheter, StatLock, Patients indicated to have an intravenous catheter placed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Interrad MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 May 2009 (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.
To prospectively monitor the safety and performance of the catheter securement device in subjects whose catheter is secured with the Interrad Medical SecureAcath device.
Detailed description
Peripherally inserted central catheters (PICCs) and Central Venous Catheter (CVC) are widely used to deliver fluids directly to the central venous system and can remain in place for as short as a few days to as long as months. One of the highest risks in the use of these catheters is infection, both local and systemic. Currently, these catheters are secured by either sutures or adhesive patches. Sutures can create additional potential entry points for bacteria whereas both sutures and adhesive securement patches hold the catheter hub to the skin resulting in increased difficulty cleaning around the catheter entry site. Furthermore, securing a catheter outside the skin away from the catheter entry point, as with sutures or adhesive securement patches may potentiate pistoning of the catheter which is also believed to possibly increase infection risks. A second risk of intravenous catheter use is dislodgement during normal use and site maintenance. These catheters are often manipulated multiple times a day for blood sampling or injection of fluids. During manipulation, the catheter can be dislodged thus requiring an unplanned replacement of the catheter.
Interrad Medical has developed a means to secure indwelling catheters using a small subcutaneous anchor. With this system, cleaning around the catheter entry site is made easier and can be more thorough. The system is also designed to minimize the risk of catheter dislodgement because once the anchor is deployed, the catheter remains secured. This may simplify dressing changes compared to adhesive devices such as Statlock, which requires the catheter be released from the device and therefore be unsecured during dressing changes.
The objective of this post-market study is to monitor the safety and performance of the SecurAcath when used to secure the catheter to the insertion site via a subcutaneous anchor. The data collected may provide insight for future enhancements to improve the safety and utility of the device. It also provides a means for an early warning of any identified safety issues, and allows physicians to share their experiences thereby improve the quality of care provided to the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated to have a central catheter placed at a hospital or private practice clinic are included in the study population.
Key inclusion criteria (2 listed)
- Age 18 or older
- Requires an intravenous catheter to be placed
Key exclusion criteria (12 listed)
- Inability to understand the study or a history of non-compliance with medical advice.
- Unwilling or unable to sign Informed Consent Form (ICF).
- Had a previous catheter placed in the same side within the last 3 months.
- Known central venous thrombosis or occlusion or stenosis on the side of the body to be used for the catheter.
- History of upper extremity venous thrombosis on the side of the body to be used for the catheter.
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 |
|---|---|---|
| SecurAcath Securement SystemAlso: PICC securement systemSubcutaneous catheter securement system | Device | – |
Primary outcome
Device Securement Success: defined as the percent of devices implanted and explanted without malfunction or device related complications attributed to the subcutaneous securement system.
Time frame: Timeframe is the length of time the patient has the catheter in place. Can vary depending on the indication for the catheter (anywhere from 48 hours post-procedure to 6 months or more).
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 31 Jan 2012.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter, run by Interrad Medical at 4 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 12 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 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Device Securement Success: defined as the percent of devices implanted and explanted without malfunction or device related complications attributed to the subcutaneous securement system. (time frame: Timeframe is the length of time the patient has the catheter in place. Can vary depending on the indication for the catheter (anywhere from 48 hours post-procedure to 6 months or more).). 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 31 Jan 2012.