N/A
N=30
Evaluation of the Surfacer System Approach to Central Venous Access
Venous Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT03209050 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Aug 2021
Primary outcome: Primary: Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter — 30 participants — p=0.5
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Central Venous Access Placement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merit Medical Systems, Inc.
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter |
30 | 0.5 |
| 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 |
30 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03209050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.