US Post-Market Surveillance Study of the Surfacer System

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. A minimum of 30 patients will be enrolled in the study, all cases to be performed un-proctored at up to 12 sites in the United States, with no site enrolling more than 6 subjects. All patients enrolled will sign an informed consent form for use of their data. Investigators will invite patients who will be treated with the device in accordance with the approved labeling and who met enrollment criteria to join the study. ;

Study Design

Related Conditions & MeSH terms

Venous Disease

Clinical Trial Details

NCT number	NCT05050799
Study type	Observational
Source	Merit Medical Systems, Inc.
Contact	Casey Holland, MS
Phone	6178420251
Email	casey.holland@merit.com
Status	Recruiting
Phase
Start date	February 8, 2022
Completion date	August 31, 2024

View Details

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