Eligibility |
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
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