Clinical trial NCT04263649: Prospective Observational Study of the Power PICC Family of Devices and Accessories
Official title: Prospective Observational Study of the Power PICC Family of Devices and Accessories
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripherally Inserted Central Catheter
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2020-02-11
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patients who require a PICC device in a primary care facility.

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period.
timeFrame: from insertion though removal or 180 days, whichever comes first
Secondary outcomes:
measure: Secondary Safety: Incidence of Phlebitis
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Safety: Incidence of Extravasation
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Safety: Incidence of Local Infection
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Safety: Incidence of Catheter-related Bloodstream Infection.
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Safety: Incidence of Accidental Dislodgement.
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Safety: Incidence of Vessel Laceration.
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Safety: Incidence of Vessel Perforation.
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Performance: Percent of Patent Catheters
timeFrame: from insertion though removal or 180 days, whichever comes first
measure: Secondary Performance: Percent of Placement Success in Single Insertion Attempt
timeFrame: during the insertion procedure
measure: Secondary Performance - Usability: Ease of Insertion
timeFrame: during the insertion procedure
Other outcomes:
measure: Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used
timeFrame: during the insertion procedure
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt
city: Vienna
country: Austria
facility: Medizinische Universität Wien
city: Leuven
country: Belgium
facility: University Hospitals KU Leuven
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Sønderborg
country: Denmark
facility: Sygehus Soenderjylland, Sønderborg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
state: Piedmont
city: Turin
country: Italy
facility: A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette
state: Piedmont
city: Ivrea
country: Italy
facility: Ospedale Civile di Ivrea
state: Piemonte
city: Bolzano
country: Italy
facility: Ospedale Centrale di Bolzano
state: Trentino
city: Napoli
country: Italy
facility: Azienda Ospedaliera dei Colli - Monaldi
city: Den Haag
country: Netherlands
facility: HAGA Ziekenhuis
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr Josep Trueta
city: Zürich
country: Switzerland
facility: Institut für Diagnostische und Interventionelle Radiologie
Study officials:
affiliation: Becton, Dickinson and Company
name: Klaus Hoerauf, MD
role: STUDY_DIRECTOR
References: