PICC Asymptomatic Thrombosis Study: A Pilot Study

Access Vascular Inc

Status: Terminated

Conditions: Peripheral ICC

Treatments: Device: Thermoplastic Polyurethane; Device: Hydrophilic Biomaterial

Study type: Interventional

Funder types: Industry

Identifiers

NCT04920929

CLIN 20-002

Details and patient eligibility

About

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.

Full description

This study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Is pregnant, lactating, or is planning to become pregnant during the time of the study
2. 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
3. Venous thrombosis in any portion of the vein to be catheterized
4. Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy
5. Orthopedic or neurological conditions affecting the extremity
6. Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers, within a month of patient enrollment start
7. 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.)
8. Patient has relinquished control of care to a guardian and/or facility
9. 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
10. Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Hydrophilic BioMaterial

Active Comparator group

Description:

Hydrophilic BioMaterial- HydroPICC

Treatment:

Device: Hydrophilic Biomaterial

Thermoplastic Polyurethane

Active Comparator group

Description:

TPU- 4 French Single Lumen PowerPICC

Treatment:

Device: Thermoplastic Polyurethane