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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04920929
Other study ID # CLIN 20-002
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 15, 2021
Est. completion date October 7, 2021

Study information

Verified date November 2022
Source Access Vascular Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date October 7, 2021
Est. primary completion date October 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Hydrophilic Biomaterial
PICC made out of a Hydrophilic Biomaterial
Thermoplastic Polyurethane
PICC made out of a thermoplastic polyurethane material

Locations

Country Name City State
United States Beaumont Hospital Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
Access Vascular Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Asymptomatic Thrombosis Rate Rate of asymptomatic thrombosis measured using ultrasound technology for each group 7 days post insertion
Secondary Symptomatic Thrombosis Rate Rate of symptomatic thrombosis measured using ultrasound technology 14 days post insertion
Secondary Symptomatic Thrombosis Rate Rate of symptomatic thrombosis measured using ultrasound technology 7 days post insertion
See also
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