PICC Asymptomatic Thrombosis Study: A Pilot Study

Stopped early · Not applicable

Conditions studied: Peripheral ICC

In brief

The study purpose is to perform a preliminary, comparative evaluation of the Hydrophilic Biomaterial technology to confirm the performance of the catheter, by using UltraSound technology in-vivo.

Key facts

Study ID

NCT04920929

Run by

Access Vascular Inc

People needed

7

Starts

2021-07-15

Expected to finish

2021-10-07

Last updated by the study team

2022-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is indicated for a medically necessary PICC for therapeutic delivery medication
• Patient is eligible to receive a single lumen PICC
• Patient is an adult who is prescribed a PICC line
• Patient's expected duration of treatment requiring a PICC for a minimum of 16 days post device implantation
• Patient understands and is willing to comply with all study requirements and has voluntarily signed the Informed Consent Form (ICF).

You may not qualify if…

• Is pregnant, lactating, or is planning to become pregnant during the time of the study
• Has been previously enrolled in this post market clinical evaluation, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
• Venous thrombosis in any portion of the vein to be catheterized
• Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
• Orthopedic or neurological conditions affecting the extremity
• Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers, within a month of patient enrollment start
• Patients who are on anticoagulation therapy prior to the study (10-14 days). Note: (If patients are placed on anticoagulation (low dose) therapy while hospitalized, these patients are allowed.)
• Patient has relinquished control of care to a guardian and/or facility
• Patient has any significant medical or physical condition that, in the opinion of the PI, would make the subject unsuitable for participation in the post market clinical evaluation
• Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Where it is running

• Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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