Prospective SecurAcath Subcutaneous Securement Trial

NCT00903539 | Completed

• 1 other identifier: 1180-001
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Central Venous Catheter

Keywords

Peripherally Inserted Central Catheter; Central Venous Catheter; Intravenous Catheter; StatLock; Patients indicated to have an intravenous catheter placed

Outcome Measures

Primary Outcomes (1)

• Device Securement Success: defined as the percent of devices implanted and explanted without malfunction or device related complications attributed to the subcutaneous securement system.

  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).

Interventions

SecurAcath Securement System DEVICE

Subcutaneous catheter securement system

Also known as: PICC securement system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated to have a central catheter placed at a hospital or private practice clinic are included in the study population.

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.

Sponsors & Collaborators

• Interrad Medical: lead

Study Sites (4)

North Memorial Hospital - Minneapolis Radiology

Robbinsdale, Minnesota, 55422, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

Great Basin Imaging

Carson City, Nevada, 89706, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

US (4)