Peripherally Inserted Central CatheterNCT04263649
Prospective Observational Study of the Power PICC Family of Devices and Accessories
An observational study of Peripherally Inserted Central Catheter, run by Becton, Dickinson and Company at 14 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripherally Inserted Central Catheter
- What is being tested?
- Peripherally Inserted Central Catheter
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 14 sitesin 9 countries
- Study dates
- 18 Jun 2020to 5 Jan 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patients who require a PICC device in a primary care facility.
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
14 sites in 9 countries.
14 sites in 9 countries
Italy5 sites
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, 15121
Ospedale Centrale di Bolzano
Bolzano, Trentino-Alto Adige, 39100
Ospedale Civile di Ivrea
Ivrea, Piedmont, 10015
Azienda Ospedaliera dei Colli - Monaldi
Naples
A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette
Turin, Piedmont, 10126
Austria2 sites
Klinikum Klagenfurt
Klagenfurt
Medizinische Universität Wien
Vienna, A-1090
Switzerland1 site
Institut für Diagnostische und Interventionelle Radiologie
Zurich, 8091
About this study
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.
Read the 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.
- Conditions
- Peripherally Inserted Central Catheter
- Being tested
- Peripherally Inserted Central Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripherally Inserted Central CatheterDevice
insertion of a Peripherally Inserted Central Catheter (PICC)
| Study group | Role | What they receive |
|---|---|---|
| All subjects | patients who require a PICC Receives: Device: Peripherally Inserted Central Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from insertion though removal or 180 days, whichever comes first
Secondary outcomes (11)
Secondary Safety: 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
Measured: from insertion though removal or 180 days, whichever comes first
Secondary Safety: 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
Measured: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Local Infection
Incidence of any new occurrence of local infection
Measured: 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
Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection
Measured: from insertion though removal or 180 days, whichever comes first
Secondary Safety: 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.
Measured: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Accidental Dislodgement.
Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement.
Measured: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Vessel Laceration.
Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel.
Measured: from insertion though removal or 180 days, whichever comes first
Secondary Safety: Incidence of Vessel Perforation.
Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel.
Measured: from insertion though removal or 180 days, whichever comes first
Secondary Performance: Percent of Patent Catheters
Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters.
Measured: from insertion though removal or 180 days, whichever comes first
Secondary Performance: 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
Measured: during the insertion procedure
Secondary Performance - Usability: Ease of Insertion
Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale)
Measured: during the insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start18 Jun 2020
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripherally Inserted Central CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Klaus Hoerauf, MD, Study director, Becton, Dickinson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263649
- Sponsor's protocol ID
- MDS-19PICCEU01
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2020
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39349374
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of the Power PICC Family of Devices and Accessories
- ClinicalTrials.gov ID
- NCT04263649
- Acronym / sponsor ID
- MDS-19PICCEU01
- Conditions
- Peripherally Inserted Central Catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: Peripherally Inserted Central Catheterpatients who require a PICC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients who require a PICC device in a primary care facility.
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripherally Inserted Central Catheterinsertion of a Peripherally Inserted Central Catheter (PICC) | Device | All subjects |
Primary outcome
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.
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.
11 secondary outcomes
Secondary Safety: Incidence of Phlebitis
Time frame: 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
Secondary Safety: Incidence of Local Infection
Time frame: 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
Secondary Safety: Incidence of Catheter-related Bloodstream Infection.
Time frame: 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
Secondary Safety: Incidence of Vessel Laceration.
Time frame: 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
Secondary Performance: Percent of Patent Catheters
Time frame: 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
Secondary Performance - Usability: Ease of Insertion
Time frame: during the insertion procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39349374Troubil 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.
- Individual participant dataSharing planned: No
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Deep Vein Thrombosis
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Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
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Efficacy and Safety of Peripherally Inserted Central Venous Catheters
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Hoerauf, MD study director
Becton, Dickinson and Company
14 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripherally Inserted Central Catheter, run by Becton, Dickinson and Company at 14 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy, Austria, Belgium, Czechia, Denmark and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.