Status:
TERMINATED
PICC Asymptomatic Thrombosis Study: A Pilot Study
Lead Sponsor:
Access Vascular Inc
Conditions:
Peripheral ICC
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04920929
Start Date
July 15 2021
End Date
October 7 2021
Last Update
November 29 2022
Active Locations (1)
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1
Beaumont Hospital
Royal Oak, Michigan, United States, 48073