ClinicalTrials.gg
RecruitingNCT05050799Updated Nov 4, 2026

US Post-Market Surveillance Study of the Surfacer System

An observational study in Venous Disease, sponsored by Merit Medical Systems, Inc.. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Merit Medical Systems, Inc. · Observational

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 9 months later.
Updated Nov 4, 2026Primary completion movedStudy completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Venous Disease
03

In context

Lead sponsor

Merit Medical Systems, Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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 requirements in the labeling of the IFU.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • DeviceCentral 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.

06

What researchers measure

Primary outcomes

  1. Central Venous Access operational

    safe insertion of the device to facilitate central venous access

    Time frame: 24 hours

  2. Incidence of adverse events through 24 hours

    no procedural adverse events or peri procedural adverse events

    Time frame: 24 hours

07

Study locations

8 of 10 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
1 site added
Show site
  • Medstar Washington Hospital Center · Washington D.C., United States
Nov 4, 2026
Primary completion
Dec 15, 2026→Aug 31, 2027
Nov 4, 2026
Study completion
Dec 15, 2026→Aug 31, 2027
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    1 site added
    Show site
    • Medstar Washington Hospital Center · Washington D.C., United States
    Primary completion Dec 15, 2026→Aug 31, 2027
    Study completion Dec 15, 2026→Aug 31, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05050799
Responsible party
Sponsor
First posted
Sep 21, 2021
Start date
Feb 8, 2022
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Hannah Susmeyer
Contact
Hannah.Susmeyer@merit.com
978-758-6166
Vicky Brunk, RN
Contact
Vicky.Brunk@merit.com
717-873-3309

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion