Prospective Observational Study of the Power PICC Family of Devices and Accessories
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All subjects patients who require a PICC |
Device: Peripherally Inserted Central Catheter
insertion of a Peripherally Inserted Central Catheter (PICC)
|
Outcome Measures
Primary Outcome Measures
- Incidence of venous thrombosis [from insertion though removal or 180 days, whichever comes first]
Incidence of venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging
- Percent PICC remain in place through therapy [from insertion though removal or 180 days, whichever comes first]
Percent of PICCs that remain in place through the required therapy time period
Secondary Outcome Measures
- Incidence of phlebitis [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
- Incidence of extravasation [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
- Incidence of local infection [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
- Incidence of Catheter-related bloodstream infection [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
- Incidence of Accidental dislodgement [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
- Incidence of vessel laceration [during the insertion procedure]
Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel
- Incidence of vessel perforation [during the insertion procedure]
Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel
- Percent of patent catheters [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
- Percent of placement success in single insertion attempt [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
- Ease of insertion [during the insertion procedure]
Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinikum Klagenfurt | Klagenfurt | Austria | ||
| 2 | Medizinische Universität Wien | Vienna | Austria | A-1090 | |
| 3 | University Hospitals KU Leuven | Leuven | Belgium | B-3000 | |
| 4 | Fakultní nemocnice Olomouc | Olomouc | Czechia | ||
| 5 | Sygehus Soenderjylland, Sønderborg | Sønderborg | Denmark | 6400 | |
| 6 | Universitätsklinikum Jena | Jena | Germany | ||
| 7 | Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Piedmont | Italy | 15121 |
| 8 | A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette | Turin | Piedmont | Italy | 10126 |
| 9 | Ospedale Civile di Ivrea | Ivrea | Piemonte | Italy | 10015 |
| 10 | Ospedale Centrale di Bolzano | Bolzano | Trentino | Italy | 39100 |
| 11 | Azienda Ospedaliera dei Colli - Monaldi | Napoli | Italy | ||
| 12 | HAGA Ziekenhuis | Den Haag | Netherlands | 2545 | |
| 13 | Hospital Universitari de Girona Dr Josep Trueta | Girona | Spain | ||
| 14 | Institut für Diagnostische und Interventionelle Radiologie | Zürich | Switzerland | 8091 |
Sponsors and Collaborators
- Becton, Dickinson and Company
- FGK Clinical Research GmbH
Investigators
- Study Director: Klaus Hoerauf, MD, Becton, Dickinson and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDS-19PICCEU01