US Post-Market Surveillance Study of the Surfacer System

Launched by MERIT MEDICAL SYSTEMS, INC. · Sep 20, 2021

Keywords

ClinConnect Summary

The US Post-Market Surveillance Study of the Surfacer System is a clinical trial aimed at helping patients with venous disease who need central venous access, such as for placing catheters or nutritional lines. This study specifically focuses on individuals who have blockages in the veins of their upper body that make it difficult to access central veins using traditional methods. The trial is currently recruiting participants, and it is open to all adults aged 65 and older who can provide consent.

If you are eligible, you’ll be part of a study where doctors will observe how well the Surfacer System works in helping patients like you get the necessary venous access. To qualify, you need to have a referral for central venous access and cannot have certain types of other vein blockages or recent clots in specific blood vessels. Throughout the study, you can expect to receive close monitoring and care from the medical team as they gather important information about the effectiveness of this device. Your participation could contribute valuable insights into improving care for others with similar conditions.

Gender

ALL

Eligibility criteria

• 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