US Post-Market Surveillance Study of the Surfacer System

Merit Medical Systems

Status: Enrolling

Conditions: Venous Disease

Treatments: Device: Central Venous Access

Study type: Observational

Funder types: Industry

Identifiers

NCT05050799

CVO-P4-23-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
2. Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
3. Subjects are willing and able to give written informed consent

Exclusion criteria

1. Occlusion of the right femoral vein, right iliac vein or inferior vena cava
2. Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
3. Occlusion within the arterial system
4. Occlusion within the coronary or cerebral vasculature