US Post-Market Surveillance Study of the Surfacer System
ConditionVenous Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMerit Medical Systems, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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 requirements in the labeling of the IFU.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Central Venous Access
DeviceThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Central Venous Access operational
safe insertion of the device to facilitate central venous access
Time frame
24 hours2
Incidence of adverse events through 24 hours
no procedural adverse events or peri procedural adverse events
Time frame
24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov