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

Peripherally Inserted Central Catheter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263649
• Other study ID #: MDS-19PICCEU01
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: March 1, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Peripherally Inserted Central Catheter

Intervention

Device:
• Peripherally Inserted Central Catheter
insertion of a Peripherally Inserted Central Catheter (PICC)

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt	Klagenfurt
Austria	Medizinische Universität Wien	Vienna
Belgium	University Hospitals KU Leuven	Leuven
Czechia	Fakultní nemocnice Olomouc	Olomouc
Denmark	Sygehus Soenderjylland, Sønderborg	Sønderborg
Germany	Universitätsklinikum Jena	Jena
Italy	Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo	Alessandria	Piedmont
Italy	Ospedale Centrale di Bolzano	Bolzano	Trentino
Italy	Ospedale Civile di Ivrea	Ivrea	Piemonte
Italy	Azienda Ospedaliera dei Colli - Monaldi	Napoli
Italy	A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette	Turin	Piedmont
Netherlands	HAGA Ziekenhuis	Den Haag
Spain	Hospital Universitari de Girona Dr Josep Trueta	Girona
Switzerland	Institut für Diagnostische und Interventionelle Radiologie	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Becton, Dickinson and Company	FGK Clinical Research GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Denmark,  Germany,  Italy,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of vessel perforation	Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel	during the insertion procedure
Secondary	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
Secondary	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
Secondary	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