US Post-Market Surveillance Study of the Surfacer System
US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)
Merit Medical Systems, Inc.
30 participants
Feb 8, 2022
OBSERVATIONAL
Conditions
Summary
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.
Eligibility
Inclusion Criteria3
- Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
- Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
- Subjects are willing and able to give written informed consent
Exclusion Criteria4
- Occlusion of the right femoral vein, right iliac vein or inferior vena cava
- Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
- Occlusion within the arterial system
- Occlusion within the coronary or cerebral vasculature
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Interventions
The Surfacer® Inside-Out® Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT05050799