PICC Asymptomatic Thrombosis Study: A Pilot Study
Primary Purpose
Peripheral ICC
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrophilic Biomaterial
Thermoplastic Polyurethane
Sponsored by
About this trial
This is an interventional other trial for Peripheral ICC
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
Sites / Locations
- Beaumont Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hydrophilic BioMaterial
Thermoplastic Polyurethane
Arm Description
Hydrophilic BioMaterial- HydroPICC
TPU- 4 French Single Lumen PowerPICC
Outcomes
Primary Outcome Measures
Asymptomatic Thrombosis Rate
Rate of asymptomatic thrombosis measured using ultrasound technology for each group
Secondary Outcome Measures
Symptomatic Thrombosis Rate
Rate of symptomatic thrombosis measured using ultrasound technology
Symptomatic Thrombosis Rate
Rate of symptomatic thrombosis measured using ultrasound technology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04920929
Brief Title
PICC Asymptomatic Thrombosis Study: A Pilot Study
Official Title
A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Enrollment too low, not meeting objectives
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Access Vascular Inc
4. Oversight
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
Data Monitoring Committee
No
5. 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.
Detailed Description
This study will compare two different materials to evaluate asymptomatic thrombosis using ultrasound technology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral ICC
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrophilic BioMaterial
Arm Type
Active Comparator
Arm Description
Hydrophilic BioMaterial- HydroPICC
Arm Title
Thermoplastic Polyurethane
Arm Type
Active Comparator
Arm Description
TPU- 4 French Single Lumen PowerPICC
Intervention Type
Device
Intervention Name(s)
Hydrophilic Biomaterial
Other Intervention Name(s)
HydroPICC
Intervention Description
PICC made out of a Hydrophilic Biomaterial
Intervention Type
Device
Intervention Name(s)
Thermoplastic Polyurethane
Other Intervention Name(s)
PowerPICC
Intervention Description
PICC made out of a thermoplastic polyurethane material
Primary Outcome Measure Information:
Title
Asymptomatic Thrombosis Rate
Description
Rate of asymptomatic thrombosis measured using ultrasound technology for each group
Time Frame
7 days post insertion
Secondary Outcome Measure Information:
Title
Symptomatic Thrombosis Rate
Description
Rate of symptomatic thrombosis measured using ultrasound technology
Time Frame
14 days post insertion
Title
Symptomatic Thrombosis Rate
Description
Rate of symptomatic thrombosis measured using ultrasound technology
Time Frame
7 days post insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Bahl, MD
Organizational Affiliation
Beaumont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PICC Asymptomatic Thrombosis Study: A Pilot Study
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