Peripheral ICC
Conditions
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.
Interventions
DEVICEHydrophilic Biomaterial
PICC made out of a Hydrophilic Biomaterial
DEVICEThermoplastic Polyurethane
PICC made out of a thermoplastic polyurethane material
Sponsors
Access Vascular Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asymptomatic Thrombosis Rate | 7 days post insertion | Rate of asymptomatic thrombosis measured using ultrasound technology for each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Thrombosis Rate | 14 days post insertion | Rate of symptomatic thrombosis measured using ultrasound technology |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hydrophilic BioMaterial Hydrophilic BioMaterial- HydroPICC
Hydrophilic Biomaterial: PICC made out of a Hydrophilic Biomaterial | 3 |
| Thermoplastic Polyurethane TPU- 4 French Single Lumen PowerPICC
Thermoplastic Polyurethane: PICC made out of a thermoplastic polyurethane material | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | Thermoplastic Polyurethane | Total | Hydrophilic BioMaterial |
|---|---|---|---|
| Age, Continuous | 63.3 Years STANDARD_DEVIATION 2.28 | 63.6 Years STANDARD_DEVIATION 9.48 | 65.0 Years STANDARD_DEVIATION 14.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 2 / 3 | 1 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Asymptomatic Thrombosis Rate
Rate of asymptomatic thrombosis measured using ultrasound technology for each group
Time frame: 7 days post insertion
Population: number of subjects with asymptomatic thrombosis measured at Day 7 post insertion using ultrasound technology
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydrophilic BioMaterial | Asymptomatic Thrombosis Rate | 2 Participants |
| Thermoplastic Polyurethane | Asymptomatic Thrombosis Rate | 1 Participants |
Secondary
Symptomatic Thrombosis Rate
Rate of symptomatic thrombosis measured using ultrasound technology
Time frame: 14 days post insertion
Population: number of subjects with symptomatic thrombosis measured using ultrasound technology at day 14
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydrophilic BioMaterial | Symptomatic Thrombosis Rate | 0 Participants |
| Thermoplastic Polyurethane | Symptomatic Thrombosis Rate | 0 Participants |
Secondary
Symptomatic Thrombosis Rate
Rate of symptomatic thrombosis measured using ultrasound technology
Time frame: 7 days post insertion
Population: number of subjects with symptomatic thrombosis measured with ultrasound technology at day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hydrophilic BioMaterial | Symptomatic Thrombosis Rate | 0 Participants |
| Thermoplastic Polyurethane | Symptomatic Thrombosis Rate | 0 Participants |