Prospective Observational Study of the Power PICC Family of Devices and Accessories

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Peripherally Inserted Central Catheter

Treatments: Device: Peripherally Inserted Central Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT04263649

MDS-19PICCEU01

Details and patient eligibility

About

Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.

Full description

Single-arm, post-market, observational, prospective study to asses the safety and performance of the Power PICC Power PICC family of devices and its accessories in a real-world setting. The study will only enroll patients that need a Power PICC catheter as part of their medical care. Patients will be followed from insertion through removal, or up to 180 days (whichever comes first). Data collected will be gathered from the patient's medical chart.

Enrollment: 450 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient, regardless of age or gender, for which the investigator has decided that one of the PowerPICC study devices for either short-or long-term venous access should be inserted as standard of care
• Expected to be available for observation through the duration of PICC therapy (including outpatient therapy, if applicable)
• Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.)

Exclusion criteria

• Presence of any device-related infection, bacteremia, or septicemia is known or suspected
• Body size is insufficient to accommodate the size of implanted device
• Known or suspected to be allergic to materials contained in the device
• History of irradiation of prospective insertion site
• Previous episode(s) of venous thrombosis or vascular surgical procedures at the prospective placement site
• Local tissue factors which would prevent proper device stabilization and/or access

Trial design

450 participants in 1 patient group

All subjects

Description:

patients who require a PICC

Treatment:

Device: Peripherally Inserted Central Catheter