Recruiting

Surfacer System

Sponsor:

Merit Medical Systems, Inc.

Code:

NCT05050799

Conditions

Venous Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Central Venous Access

Study Details

Brief 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.

Conditions

Venous Disease

Study ID

NCT05050799

Start date

Feb 8, 2022

Status verified date

May, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Central Venous Access operational [ Time Frame: 24 hours ]
  • Incidence of adverse events through 24 hours [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Hannah Susmeyer

978-758-6166Hannah.Susmeyer@merit.com

Vicky Brunk, RN

717-873-3309Vicky.Brunk@merit.com

Locations

Sarasota Memorial Health Care System

Recruiting

Sarasota, Florida, United States, 34239

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Ohio State University Hospital

Recruiting

Columbus, Ohio, United States, 43210

Baylor Scott & White Heart and Vascular Hospital

Recruiting

Dallas, Texas, United States, 75226

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

St. Mark's Hospital

Recruiting

Millcreek, Utah, United States, 84124

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

Merit Medical Systems, Inc.

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merit Medical Systems, Inc. on 2026-06-01.