PICC Asymptomatic Thrombosis Study: A Pilot Study

Not Applicable

Terminated

• Conditions: Peripheral ICC
• Interventions: Device: Thermoplastic Polyurethane; Device: Hydrophilic Biomaterial

• Registration Number: NCT04920929
• Lead Sponsor: Access Vascular Inc

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.

Study Timeline

• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-10
• Study Start: 2021-07-15
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-07
• Results First Submitted: 2022-10-07
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-03
• Results First Posted: 2022-11-29
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermoplastic Polyurethane	Thermoplastic Polyurethane	TPU- 4 French Single Lumen PowerPICC
Hydrophilic BioMaterial	Hydrophilic Biomaterial	Hydrophilic BioMaterial- HydroPICC

Primary Outcome Measures

Name	Time	Method
Asymptomatic Thrombosis Rate	7 days post insertion	Rate of asymptomatic thrombosis measured using ultrasound technology for each group

Secondary Outcome Measures

Name	Time	Method
Symptomatic Thrombosis Rate	7 days post insertion	Rate of symptomatic thrombosis measured using ultrasound technology

Trial Locations

Locations (1)

Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States