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OpenTrials
Completed

NCT Number: NCT04263649

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

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.

Completed

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Key information

Conditions

Peripherally Inserted Central Catheter

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Klagenfurt, Klagenfurt, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripherally Inserted Central Catheter

Device

insertion of a Peripherally Inserted Central Catheter (PICC)

Primary outcomes

  1. Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access.

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging.

  2. Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period.

    Time frame: from insertion though removal or 180 days, whichever comes first

    PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 180-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled. Most patients who died during the study had the device still in place at the time of death and hence were considered as having completed the therapy.

Secondary outcomes

  1. Secondary Safety: Incidence of Phlebitis

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation

  2. Secondary Safety: Incidence of Extravasation

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter

  3. Secondary Safety: Incidence of Local Infection

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of any new occurrence of local infection

  4. Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection

  5. Secondary Safety: Incidence of Catheter-related Bloodstream Infection.

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of Catheter-related bloodstream infection where Catheter-related bloodstream infection is defined as positive blood culture(s) with a microorganism not related to another source (e.g., UTI) OR positive blood culture(s) with microorganism matching catheter tip culture OR blood cultures from peripheral venous puncture and PICC positive with the same microorganism.

  6. Secondary Safety: Incidence of Accidental Dislodgement.

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement.

  7. Secondary Safety: Incidence of Vessel Laceration.

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel.

  8. Secondary Safety: Incidence of Vessel Perforation.

    Time frame: from insertion though removal or 180 days, whichever comes first

    Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel.

  9. Secondary Performance: Percent of Patent Catheters

    Time frame: from insertion though removal or 180 days, whichever comes first

    Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters.

  10. Secondary Performance: Percent of Placement Success in Single Insertion Attempt

    Time frame: during the insertion procedure

    Percent of placement success in single insertion attempt defined as placement success defined as single insertion attempt, proper tip location, and patent catheter

  11. Secondary Performance - Usability: Ease of Insertion

    Time frame: during the insertion procedure

    Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale)

Other outcomes

  1. Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used

    Time frame: during the insertion procedure

    The percentage of Sherlock 3CG Pre-Loaded Stylet that aided in guidance and placement of the catheter, when used

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Collaborators

  • FGK Clinical Research GmbH

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2020
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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