PICC Asymptomatic Thrombosis Study: A Pilot Study

NCT ID: NCT04920929

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2021-10-07

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.

Conditions

Peripheral ICC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hydrophilic BioMaterial

Hydrophilic BioMaterial- HydroPICC

Group Type: ACTIVE_COMPARATOR

Hydrophilic Biomaterial

Intervention Type: DEVICE

PICC made out of a Hydrophilic Biomaterial

Thermoplastic Polyurethane

TPU- 4 French Single Lumen PowerPICC

Group Type: ACTIVE_COMPARATOR

Thermoplastic Polyurethane

Intervention Type: DEVICE

PICC made out of a thermoplastic polyurethane material

Interventions

Hydrophilic Biomaterial

PICC made out of a Hydrophilic Biomaterial

Intervention Type: DEVICE

Thermoplastic Polyurethane

PICC made out of a thermoplastic polyurethane material

Intervention Type: DEVICE

Other Intervention Names

HydroPICC; PowerPICC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Access Vascular Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Bahl, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital

Locations

Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLIN 20-002

Identifier Type: -

Identifier Source: org_study_id