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.

Study Overview

• Status: Completed
• Conditions: Peripherally Inserted Central Catheter
• Intervention / Treatment: Device: Peripherally Inserted Central Catheter

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 Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Austria
  • Klagenfurt, Austria
    • Klinikum Klagenfurt
  • Vienna, Austria, A-1090
    • Medizinische Universität Wien
• Belgium
  • Leuven, Belgium, B-3000
    • University Hospitals KU Leuven
• Czechia
  • Olomouc, Czechia
    • Fakultní nemocnice Olomouc
• Denmark
  • Sønderborg, Denmark, 6400
    • Sygehus Soenderjylland, Sønderborg
• Germany
  • Jena, Germany
    • Universitätsklinikum Jena
• Italy
  • Napoli, Italy
    • Azienda Ospedaliera dei Colli - Monaldi
  • Piedmont
    • Alessandria, Piedmont, Italy, 15121
      • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
    • Turin, Piedmont, Italy, 10126
      • A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette
  • Piemonte
    • Ivrea, Piemonte, Italy, 10015
      • Ospedale Civile di Ivrea
  • Trentino
    • Bolzano, Trentino, Italy, 39100
      • Ospedale Centrale di Bolzano
• Netherlands
  • Den Haag, Netherlands, 2545
    • Haga ziekenhuis
• Spain
  • Girona, Spain
    • Hospital Universitari de Girona Dr Josep Trueta
• Switzerland
  • Zürich, Switzerland, 8091
    • Institut für diagnostische und interventionelle Radiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patients who require a PICC device in a primary care facility.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All subjects; patients who require a PICC	Device: Peripherally Inserted Central Catheter; insertion of a Peripherally Inserted Central Catheter (PICC)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Collaborators: FGK Clinical Research GmbH

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MDS-19PICCEU01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes