TerminatedNot Applicable

The PROOF Study: The PICC Related Obstruction Of Flow Study

Stopped: Low enrollment

United States, Canada, Switzerland57 participantsStarted 2013-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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):
✕. 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

What they're measuring

Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound

Timeframe: 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)

Trial details

NCT IDNCT01921114

SponsorAngiodynamics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-07

Results submitted2019-05-16

View on ClinicalTrials.gov More Patients Indicated for a PICC for Any Medical Condition trials