Prospective SecurAcath Subcutaneous Securement Trial

Completed

Conditions studied: Central Venous Catheter

In brief

To prospectively monitor the safety and performance of the catheter securement device in subjects whose catheter is secured with the Interrad Medical SecureAcath device.

Key facts

Study ID

NCT00903539

Run by

Interrad Medical

People needed

217

Starts

2009-01-01

Expected to finish

2011-05-01

Last updated by the study team

2012-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Requires an intravenous catheter to be placed

You may not qualify if…

• 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.
• 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.

Where it is running

• North Memorial Hospital - Minneapolis Radiology — Robbinsdale, Minnesota, United States
• HealthEast St. Joseph's Hospital — Saint Paul, Minnesota, United States
• Great Basin Imaging — Carson City, Nevada, United States
• Albany Medical Center — Albany, New York, United States

Full record on ClinicalTrials.gov

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