PICC Asymptomatic Thrombosis Study: A Pilot Study (NCT04920929) | Clinical Trial Compass
TerminatedNot Applicable
PICC Asymptomatic Thrombosis Study: A Pilot Study
Stopped: Enrollment too low, not meeting objectives
United States7 participantsStarted 2021-07-15
Plain-language 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.
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
✓. 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.)