PICC Asymptomatic Thrombosis Study: A Pilot Study

NCT04920929 | Terminated Results FDA Device

• 1 other identifier: CLIN 20-002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral ICC

Outcome Measures

Primary Outcomes (1)

• Asymptomatic Thrombosis Rate

  Rate of asymptomatic thrombosis measured using ultrasound technology for each group

  7 days post insertion

Secondary Outcomes (2)

• Symptomatic Thrombosis Rate

  14 days post insertion

• Symptomatic Thrombosis Rate

  7 days post insertion

Study Arms (2)

Hydrophilic BioMaterial

ACTIVE COMPARATOR

Hydrophilic BioMaterial- HydroPICC

Device: Hydrophilic Biomaterial

Thermoplastic Polyurethane

ACTIVE COMPARATOR

TPU- 4 French Single Lumen PowerPICC

Device: Thermoplastic Polyurethane

Interventions

Hydrophilic Biomaterial DEVICE

PICC made out of a Hydrophilic Biomaterial

Also known as: HydroPICC

Hydrophilic BioMaterial

Thermoplastic Polyurethane DEVICE

PICC made out of a thermoplastic polyurethane material

Also known as: PowerPICC

Thermoplastic Polyurethane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Access Vascular Inc: lead

Study Sites (1)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Results Point of Contact

• Title: Brian Hanley
• Organization: Access Vascular Inc.

bhanley@accessvascularinc.com

1-781-538-6594

Study Officials

• Amit Bahl, MD

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized control

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: July 15, 2021
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: November 29, 2022
• Results First Posted: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)