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New catheter device offers hope for patients with blocked veins

NCT ID NCT05050799

Disease control Sponsor: Merit Medical Systems, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called the Surfacer Inside-Out Access Catheter System. It is designed to help patients who have blocked veins in their upper body and cannot get a standard central line. The study will enroll 30 people and track how safely the device works and any side effects within 24 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Surfacer Inside-Out Access Catheter System
What this could lead to
If successful, this device could provide a safe way to place catheters in patients with blocked upper body veins, avoiding more invasive procedures.
What could go wrong
This is a small, early post-market study with only 30 participants. The device may not work for everyone, and there are risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

superior vena cava syndrome vein disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor Scott & White Heart and Vascular Hospital

    RECRUITING

    Dallas, Texas, 75226, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Flow Vascular Institute

    COMPLETED

    Pasadena, Texas, 77504, United States

  • Ohio State University Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Pima Heart and Vascular

    COMPLETED

    Tucson, Arizona, 85704, United States

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • St. Mark's Hospital

    RECRUITING

    Millcreek, Utah, 84124, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

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