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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripherally Inserted Central Catheter

Intervention / Treatment
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* Device: Peripherally Inserted Central Catheter


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects<br>patients who require a PICC | Device: Peripherally Inserted Central Catheter<br>* insertion of a Peripherally Inserted Central Catheter (PICC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of venous thrombosis | Incidence of venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging | from insertion though removal or 180 days, whichever comes first | 
| Percent PICC remain in place through therapy | Percent of PICCs that remain in place through the required therapy time period | from insertion though removal or 180 days, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of phlebitis | Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation | from insertion though removal or 180 days, whichever comes first | 
| Incidence of extravasation | Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter | from insertion though removal or 180 days, whichever comes first | 
| Incidence of local infection | Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection | from insertion though removal or 180 days, whichever comes first | 
| Incidence of Catheter-related bloodstream infection | 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 | from insertion though removal or 180 days, whichever comes first | 
| Incidence of Accidental dislodgement | Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement | from insertion though removal or 180 days, whichever comes first | 
| Incidence of vessel laceration | Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel | during the insertion procedure | 
| Incidence of vessel perforation | Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel | during the insertion procedure | 
| Percent of patent catheters | Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters | from insertion though removal or 180 days, whichever comes first | 
| Percent of placement success in single insertion attempt | Percent of placement success in single insertion attempt defined as placement success defined as single insertion attempt, proper tip location, and patent catheter | during the insertion procedure | 
| Ease of insertion | Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale) | during the insertion procedure |