NCT05050799

US Post-Market Surveillance Study of the Surfacer System

US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Merit Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Venous Disease

Interventions

Type	Name	Description
DEVICE	Central Venous Access	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.

Timeline

• Start date: 2022-02-08
• Primary completion: 2026-12-15
• Completion: 2026-12-15
• First posted: 2021-09-21
• Last updated: 2025-08-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study