Patients Indicated for a PICC for Any Medical ConditionPROOFNCT01921114
The PROOF Study: The PICC Related Obstruction Of Flow Study
A study testing BioFlo™ Peripherally Inserted Central Catheter (PICC) and Bard® Dual-Lumen PowerPICC SOLO2® in people with Patients Indicated for a PICC for Any Medical Condition, run by Angiodynamics, Inc. at 5 sites in 3 countries.
Trial summary
The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to another commercially available PICC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Indicated for a PICC for Any Medical Condition
- What is being tested?
- BioFlo™ Peripherally Inserted Central Catheter (PICC) and Bard® Dual-Lumen PowerPICC SOLO2®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 2013to Aug 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is indicated for a PICC based on institutional practices
- Is ≥ 18 years of age
- Is expected to require use of a PICC for a minimum of 10 days
- Has normal findings on initial ultrasonography (complete Ultrasound Checklist)
- Vein used for PICC placement must be a minimum of 5mm in diameter
- Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study (or has the ICF signed by the patient's legal representative)
Who cannot join
- Anticipates or has presence of dialysis grafts or other ipsilateral intraluminal devices, including pacemakers (with the exception of peripheral IV catheters)
- Has current or anticipated hematologic derangements, including:
- thrombocytopenia
- history of heparin-induced thrombocytopenia
- coagulopathy (International Normalized Ratio 2.5 or greater)
- established diagnosis of hypercoagulable syndrome (e.g., protein C and S deficiency, anti-phospholipid antibody or polycythemia) or requires systemic therapeutic anticoagulation (Note: The following prophylactic treatments are allowed: subcutaneous heparin or enoxaparin sodium injection, and concomitant use of platelet aggregation inhibitors, e.g., Plavix/Ticlid/aspirin)
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- Has central veno-occlusive disease
- Has history of previous catheter-related thrombosis
- Has arm identified for catheterization that exhibits any of the following (and the contralateral arm is also unsuitable for PICC placement based on the same criteria):
- Current (or prior history of) venous thrombosis in all or any portion of the vein where the catheter is expected to reside
- Conditions that impede venous return from the extremity (such as paralysis or lymphedema after mastectomy)
- Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
- Anatomical distortions from surgery, injury or trauma (e.g., orthopedic conditions such as compound fractures requiring reconstructive procedures)
- Anatomical irregularities (structural, vascular, neurological) which may compromise catheter insertion or catheter care procedures in the involved extremity (e.g., reflex sympathetic dystrophy)
- Is pregnant or lactating
- Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
NorthShore University HealthSystem
Evanston, Illinois, 60201
University of Louisville/Norton Hospital
Louisville, Kentucky, 40202
University of Miami Hospital
Miami, Florida, 33136
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
About this study
Official title: A Randomized Prospective Multicenter Evaluation to Investigate the Incidence of Catheter Related Venous Thrombosis in Patients Undergoing Intravenous Therapy With the BioFlo™ Peripherally Inserted Central Catheter (PICC) or Bard® Dual-Lumen PowerPICC SOLO2®
The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to another commercially available PICC.
Read the detailed description
Purpose:
To investigate whether the BioFlo™ PICC will be associated with a reduced incidence of catheter-related venous thrombosis (including both symptomatic and asymptomatic) compared to another commercially available PICC: the Bard® PowerPICC SOLO2®
Design:
This is a randomized, multi-center clinical study. The study is designed as a two-arm prospectively controlled trial. Participants will be randomly assigned to either the study or control catheter using a 1:1 schema.
Enrollment:
Four hundred sixteen (416) patients will be enrolled at four (4) to eight (8) study sites in order to obtain 354 evaluable patients.
Study Objectives:
The primary objective of this study is to investigate the incidence of catheter-related venous thrombosis in patients receiving either the 5 Fr BioFlo™ PICC catheter or the control catheter, i.e., the 5 Fr Dual-Lumen PowerPICC SOLO2® catheter.
Secondary objectives of this study are to investigate:
- Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals
- Incidence of catheter occlusion (independently from other catheter-related complications)
Additionally, economic outcomes with respect to medical resource utilization requirements will be compared between the two catheter groups (at US sites only).
- Being tested
- BioFlo™ Peripherally Inserted Central Catheter (PICC), Bard® Dual-Lumen PowerPICC SOLO2®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFlo™ Peripherally Inserted Central Catheter (PICC)Device
Bard® Dual-Lumen PowerPICC SOLO2®Device
| Study group | Role | What they receive |
|---|---|---|
| BioFlo™ PICC | Active comparator | BioFlo™ Peripherally Inserted Central Catheter (PICC) Receives: Device: BioFlo™ Peripherally Inserted Central Catheter (PICC) |
| Bard® PowerPICC SOLO2® | Active comparator | Bard® Dual-Lumen PowerPICC SOLO2® Receives: Device: Bard® Dual-Lumen PowerPICC SOLO2® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound
Measured: 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)
Secondary outcomes (1)
Incidence of Other Catheter-related Complications
Secondary objectives of this study are to investigate:
- Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals
- Incidence of catheter occlusion (independently from other catheter-related complications)
Measured: Up to 30 days post-insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionAug 2014
Why it stopped: Low enrollment
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.
- Other trials for Patients Indicated for a PICC for Any Medical ConditionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Hahn, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921114
- Sponsor's protocol ID
- VA-BF400
- Acronym
- PROOF
- Status last verified
- May 2019
- First submitted
- 8 Aug 2013
- Last updated
- 17 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Multicenter Evaluation to Investigate the Incidence of Catheter Related Venous Thrombosis in Patients Undergoing Intravenous Therapy With the BioFlo™ Peripherally Inserted Central Catheter (PICC) or Bard® Dual-Lumen PowerPICC SOLO2®
- ClinicalTrials.gov ID
- NCT01921114
- Acronym / sponsor ID
- PROOF / VA-BF400
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Posted 17 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to another commercially available PICC.
Detailed description
Purpose:
To investigate whether the BioFlo™ PICC will be associated with a reduced incidence of catheter-related venous thrombosis (including both symptomatic and asymptomatic) compared to another commercially available PICC: the Bard® PowerPICC SOLO2®
Design:
This is a randomized, multi-center clinical study. The study is designed as a two-arm prospectively controlled trial. Participants will be randomly assigned to either the study or control catheter using a 1:1 schema.
Enrollment:
Four hundred sixteen (416) patients will be enrolled at four (4) to eight (8) study sites in order to obtain 354 evaluable patients.
Study Objectives:
The primary objective of this study is to investigate the incidence of catheter-related venous thrombosis in patients receiving either the 5 Fr BioFlo™ PICC catheter or the control catheter, i.e., the 5 Fr Dual-Lumen PowerPICC SOLO2® catheter.
Secondary objectives of this study are to investigate:
- Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals
- Incidence of catheter occlusion (independently from other catheter-related complications)
Additionally, economic outcomes with respect to medical resource utilization requirements will be compared between the two catheter groups (at US sites only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioFlo™ PICC | Active comparator | Device: BioFlo™ Peripherally Inserted Central Catheter (PICC)BioFlo™ Peripherally Inserted Central Catheter (PICC) |
| Bard® PowerPICC SOLO2® | Active comparator | Device: Bard® Dual-Lumen PowerPICC SOLO2®Bard® Dual-Lumen PowerPICC SOLO2® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is indicated for a PICC based on institutional practices
- Is ≥ 18 years of age
- Is expected to require use of a PICC for a minimum of 10 days
- Has normal findings on initial ultrasonography (complete Ultrasound Checklist)
- Vein used for PICC placement must be a minimum of 5mm in diameter
Key exclusion criteria (16 listed)
- Anticipates or has presence of dialysis grafts or other ipsilateral intraluminal devices, including pacemakers (with the exception of peripheral IV catheters)
- Has current or anticipated hematologic derangements, including:
- Has central veno-occlusive disease
- Has history of previous catheter-related thrombosis
- Has arm identified for catheterization that exhibits any of the following (and the contralateral arm is also unsuitable for PICC placement based on the same criteria):
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 |
|---|---|---|
| BioFlo™ Peripherally Inserted Central Catheter (PICC) | Device | BioFlo™ PICC |
| Bard® Dual-Lumen PowerPICC SOLO2® | Device | Bard® PowerPICC SOLO2® |
Primary outcome
Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound
Time frame: 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)
1 secondary outcome
Incidence of Other Catheter-related Complications
Time frame: Up to 30 days post-insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
David Hahn, MD principal investigator
Endeavor Health
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioFlo™ Peripherally Inserted Central Catheter (PICC) and Bard® Dual-Lumen PowerPICC SOLO2® in people with Patients Indicated for a PICC for Any Medical Condition, run by Angiodynamics, Inc. at 5 sites in 3 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, Switzerland. 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 17 May 2019). 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?
Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound (time frame: 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2019.