N/A Completed N=30 Treatment

Evaluation of the Surfacer System Approach to Central Venous Access

Venous Occlusion

Source: ClinicalTrials.gov NCT03209050 ↗

Enrolled (actual)

Serious AEs

13.3%

Results posted

Aug 2021

Primary outcomePrimary: Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter — 30 participants — p=0.5

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.