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Prospective Observational Study of the Power PICC Family of Devices and Accessories | Clinical Trials | Clareo Health

COMPLETED

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

NCT04263649•Becton, Dickinson and Company

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

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (14)

Klinikum Klagenfurt

Klagenfurt, Austria

Medizinische Universität Wien

Vienna, Austria

University Hospitals KU Leuven

Leuven, Belgium

Fakultní nemocnice Olomouc

Olomouc, Czechia

Sygehus Soenderjylland, Sønderborg

Sønderborg, Denmark

Universitätsklinikum Jena

Jena, Germany

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, Italy

Ospedale Civile di Ivrea

Ivrea, Piedmont, Italy

A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette

Turin, Piedmont, Italy

Ospedale Centrale di Bolzano

Bolzano, Trentino-Alto Adige, Italy

Key Dates

Start Date

June 18, 2020

Primary Completion Date

January 5, 2022

Completion Date

January 5, 2022

Last Updated

August 19, 2024

Enrollment

450

ACTUAL participants

Conditions

Peripherally Inserted Central Catheter

Interventions

Peripherally Inserted Central Catheter

DEVICE

Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"

NCT07209670

Peripherally Inserted Central CatheterUmbilical Venous Catheter+1 more

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COMPLETEDNA

Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution.

NCT04241926

Peripherally Inserted Central CathetersCentrally Inserted Central Catheter+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"

Single-lumen 5Fr and Triple-lumen 6Fr PICCs Are Accurate for Hemodynamic Measurement by Transpulmonary Thermodilution.

Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting

Research on the Localization Accuracy of PICC Guided by EDUG in Real World

The Application of Neck Ultrasound in the Assessment of Peripherally Inserted Central Catheter (PICC) Tip Position