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PICC Asymptomatic Thrombosis Study: A Pilot Study

Sponsor
Access Vascular Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT04920929
Collaborator
(none)
7
Enrollment
1
Location
2
Arms
2.8
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hydrophilic Biomaterial
  • Device: Thermoplastic Polyurethane
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlRandomized control
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study
Actual Study Start Date :
Jul 15, 2021
Actual Primary Completion Date :
Oct 7, 2021
Actual Study Completion Date :
Oct 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hydrophilic BioMaterial

Hydrophilic BioMaterial- HydroPICC

Device: Hydrophilic Biomaterial
PICC made out of a Hydrophilic Biomaterial
Other Names:
  • HydroPICC

    		•
    Active Comparator: Thermoplastic Polyurethane

    TPU- 4 French Single Lumen PowerPICC

    Device: Thermoplastic Polyurethane
    PICC made out of a thermoplastic polyurethane material
    Other Names:
  • PowerPICC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The primary purpose is to evaluate the incidence of early asymptomatic thrombosis between the Hydrophilic Biomaterial arm and the comparison TPU arm. [7 days post insertion]

      Asymptomatic thrombosis will be measured using ultrasound technology

    Secondary Outcome Measures

    1. The secondary objective of this study is to evaluate the symptomatic thrombosis rate in the two groups by using ultrasound technology [14 days post insertion]

      Symptomatic thrombosis will be measured using ultrasound technology

    2. The secondary objective of this study is to evaluate the symptomatic thrombosis rate in the two groups by using ultrasound technology [7 days post insertion]

      Symptomatic thrombosis will be measured using ultrasound technology

    Other Outcome Measures

    1. Another outcome is to evaluate the incidence of asymptomatic thrombosis between the Hydrophilic Biomaterial arm and the comparison TPU arm. [14 days post insertion]

      An examination of subjects with asymptomatic thrombosis at 7 days to evaluate progression of asymptomatic thrombosis.

    2. Failure rates of both PICCs [14 days post insertion]

      Compare the rates of failure between the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beaumont Hospital Royal Oak Michigan United States 48073

    Sponsors and Collaborators

    • Access Vascular Inc

    Investigators

    • Principal Investigator: Amit Bahl, MD, Beaumont Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Access Vascular Inc
    ClinicalTrials.gov Identifier:
    NCT04920929
    Other Study ID Numbers:
    • CLIN 20-002
    First Posted:
    Jun 10, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Thrombosis

    Study Results

    No Results Posted as of Nov 19, 2021