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

March 22, 2024 updated by: Becton, Dickinson and Company
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Fakultni Nemocnice Olomouc
  • Denmark
      • Sønderborg, Denmark, 6400
        • Sygehus Soenderjylland, Sønderborg
  • Germany
      • Jena, Germany
        • Universitatsklinikum 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: from insertion though removal or 180 days, whichever comes first
Incidence of symptomatic 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 Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period.
Time Frame: from insertion though removal or 180 days, whichever comes first
PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 180-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled. Most patients who died during the study had the device still in place at the time of death and hence were considered as having completed the therapy.
from insertion though removal or 180 days, whichever comes first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Safety: Incidence of Phlebitis
Time Frame: 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
from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Extravasation
Time Frame: 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
from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Local Infection
Time Frame: from insertion though removal or 180 days, whichever comes first
Incidence of any new occurrence of local infection
from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection
Time Frame: 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
from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Catheter-related Bloodstream Infection.
Time Frame: 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.
from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Accidental Dislodgement.
Time Frame: 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.
from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Vessel Laceration.
Time Frame: from insertion though removal or 180 days, whichever comes first
Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel.
from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Vessel Perforation.
Time Frame: from insertion though removal or 180 days, whichever comes first
Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel.
from insertion though removal or 180 days, whichever comes first
Secondary Performance: Percent of Patent Catheters
Time Frame: 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.
from insertion though removal or 180 days, whichever comes first
Secondary Performance: Percent of Placement Success in Single Insertion Attempt
Time Frame: 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
during the insertion procedure
Secondary Performance - Usability: Ease of Insertion
Time Frame: during the insertion procedure
Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale)
during the insertion procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used
Time Frame: during the insertion procedure
The percentage of Sherlock 3CG Pre-Loaded Stylet that aided in guidance and placement of the catheter, when used
during the insertion procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Becton, Dickinson and Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FGK Clinical Research GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Klaus Hoerauf, MD, Becton, Dickinson and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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