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

  • STATUS
    Recruiting
  • participants needed
    450
  • sponsor
    Becton, Dickinson and Company
Updated on 19 February 2024

Summary

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.

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.

Details
Condition Peripherally Inserted Central Catheter
Age 100years or below
Treatment Peripherally Inserted Central Catheter
Clinical Study IdentifierNCT04263649
SponsorBecton, Dickinson and Company
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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