Venous Occlusion
Conditions
Brief summary
Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter.
Detailed description
This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of the Surfacer System. Safety will be evaluated based on the overall rate of acute complications using the study device as compared to historical rates of device/procedure related safety events using conventional central venous access methods. Efficacy will be evaluated by the rate of transient successful central venous accesses created by the study device. A total of 30 patients are planned to be enrolled, with 10 patients initially following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites will participate in the study in the United States.
Interventions
DEVICECentral Venous Access Placement
Device inserted into the femoral vein to insert a central venous access catheter
Sponsors
Meditrial Europe Ltd.
Merit Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
patients requiring venous access
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* referred for placement of central venous access catheter * have limited or diminishing upper body venous access * have pathology impeding standard access methods * willing to give written informed consent
Exclusion criteria
* occlusion of the right femoral vein * occlusion of the iliac vein * occlusion of the inferior vena cava * contraindicated by physician * acute thrombosis within any vessel planned to be crossed by the Surfacer \*tortuous anatomy which precludes a straight line from femoral vein to subclavian * diagnosed with active pericarditis * diagnosed with active endocarditis * suspected pericardial effusion * known or suspected aneurysm or ectasia of ascending aorta * innominate artery or subclavian artery * pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter | 7 days | Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted | 7 days | Safety and Efficacy 90.0% (27/30) successful central venous catheter placements as assessed by patent open central venous access catheter. Ability to use the central venous access catheter for dialysis and infusion through 7 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Central Venous Access Placement Central venous access placement
Central Venous Access Placement: Device inserted into the femoral vein to insert a central venous access catheter | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Central Venous Access Placement |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| chronic Kidney disease | 25 Participants |
| Race/Ethnicity, Customized | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 1 / 30 |
| serious Total, serious adverse events | 4 / 30 |
Outcome results
Primary
Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter
Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Central Venous Access Placement | Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter | 30 participants |
p-value: 0.5Clopper-Pearson 95% CI
Secondary
Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted
Safety and Efficacy 90.0% (27/30) successful central venous catheter placements as assessed by patent open central venous access catheter. Ability to use the central venous access catheter for dialysis and infusion through 7 days
Time frame: 7 days
Population: patients treated with central venous access device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Central Venous Access Placement | Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted | 30 Participants |