PICC Asymptomatic Thrombosis Study: A Pilot Study

A Prospective, Randomized, PICC Asymptomatic Thrombosis Study: A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral ICC
• Intervention / Treatment: Device: Hydrophilic Biomaterial; Device: Thermoplastic Polyurethane

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asymptomatic Thrombosis Rate	Rate of asymptomatic thrombosis measured using ultrasound technology for each group	7 days post insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic Thrombosis Rate	Rate of symptomatic thrombosis measured using ultrasound technology	14 days post insertion
Symptomatic Thrombosis Rate	Rate of symptomatic thrombosis measured using ultrasound technology	7 days post insertion

Collaborators and Investigators

• Sponsor: Access Vascular Inc
• Investigators: Principal Investigator: Amit Bahl, MD, Beaumont Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): October 7, 2021
• Study Completion (Actual): October 7, 2021

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: CLIN 20-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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