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

NCT04263649 | Completed Results FDA Device

• 1 other identifier: MDS-19PICCEU01
• Study Type: observational
• Target: 450
• Locations: 9 countries
• Sites: 14

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.

Conditions

Peripherally Inserted Central Catheter

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 Outcomes (11)

• Secondary Safety: Incidence of Phlebitis

  from insertion though removal or 180 days, whichever comes first

• Secondary Safety: Incidence of Extravasation

  from insertion though removal or 180 days, whichever comes first

• Secondary Safety: Incidence 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

  from insertion though removal or 180 days, whichever comes first

• Secondary Safety: Incidence of Catheter-related Bloodstream Infection.

  from insertion though removal or 180 days, whichever comes first

Other Outcomes (1)

• Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used

  during the insertion procedure

Study Arms (1)

All subjects

patients who require a PICC

Device: Peripherally Inserted Central Catheter

Interventions

Peripherally Inserted Central Catheter DEVICE

insertion of a Peripherally Inserted Central Catheter (PICC)

All subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (14)

Klinikum Klagenfurt

Klagenfurt, Austria

Location

Medizinische Universität Wien

Vienna, A-1090, Austria

Location

University Hospitals KU Leuven

Leuven, B-3000, Belgium

Location

Fakultní nemocnice Olomouc

Olomouc, Czechia

Location

Sygehus Soenderjylland, Sønderborg

Sønderborg, 6400, Denmark

Location

Universitätsklinikum Jena

Jena, Germany

Location

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, 15121, Italy

Location

Ospedale Civile di Ivrea

Ivrea, Piedmont, 10015, Italy

Location

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

Turin, Piedmont, 10126, Italy

Location

Ospedale Centrale di Bolzano

Bolzano, Trentino-Alto Adige, 39100, Italy

Location

Azienda Ospedaliera dei Colli - Monaldi

Napoli, Italy

Location

HAGA Ziekenhuis

The Hague, 2545, Netherlands

Location

Hospital Universitari de Girona Dr Josep Trueta

Girona, Spain

Location

Institut für Diagnostische und Interventionelle Radiologie

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Troubil M, Capozzoli G, Mussa B, Hodne M, Hoerauf K, Alsbrooks K. Performance and safety of PowerPICC catheters and accessories: a prospective observational study. BMJ Open. 2024 Sep 30;14(9):e081288. doi: 10.1136/bmjopen-2023-081288.

  PMID: 39349374 DERIVED

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Becton, Dickinson and Company

gloria.viti@bd.com

00393452237718

Study Officials

• Klaus Hoerauf, MD

  Becton, Dickinson and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: June 18, 2020
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); BE (1); ES (1); CH (1); DK (1); NL (1); DE (1); CZ (1); AU (2)