PICC Asymptomatic Thrombosis Study: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
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.

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

Official Title
-----------------
A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study

Conditions
-----------------
Peripheral ICC

Intervention / Treatment
-----------------
* Device: Hydrophilic Biomaterial
* Device: Thermoplastic Polyurethane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydrophilic BioMaterial<br>Hydrophilic BioMaterial- HydroPICC | Device: Hydrophilic Biomaterial<br>* PICC made out of a Hydrophilic Biomaterial<br>* Other names: HydroPICC;|
| Active Comparator: Thermoplastic Polyurethane<br>TPU- 4 French Single Lumen PowerPICC | Device: Thermoplastic Polyurethane<br>* PICC made out of a thermoplastic polyurethane material<br>* Other names: PowerPICC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymptomatic Thrombosis Rate | Rate of asymptomatic thrombosis measured using ultrasound technology for each group | 7 days post insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic Thrombosis Rate | Rate of symptomatic thrombosis measured using ultrasound technology | 14 days post insertion | 
| Symptomatic Thrombosis Rate | Rate of symptomatic thrombosis measured using ultrasound technology | 7 days post insertion |