Venous DiseaseNCT05050799
US Post-Market Surveillance Study of the Surfacer System
An observational study of Venous Disease, run by Merit Medical Systems, Inc. at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Disease
- What is being tested?
- Central Venous Access
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 10 sitesUnited States
- Study dates
- 8 Feb 2022to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
- Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
- Subjects are willing and able to give written informed consent
Who cannot join
- Occlusion of the right femoral vein, right iliac vein or inferior vena cava
- Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
- Occlusion within the arterial system
- Occlusion within the coronary or cerebral vasculature
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 8 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
Ohio State University Hospital
Columbus, Ohio, 43210
- Recruiting
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, 75226
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
- Recruiting
St. Mark's Hospital
Millcreek, Utah, 84124
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
- Completed
Flow Vascular Institute
Pasadena, Texas, 77504
- Recruiting
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
- Completed
Pima Heart and Vascular
Tucson, Arizona, 85704
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)
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.
- Conditions
- Venous Disease
- Being tested
- Central Venous Access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Venous AccessDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Venous Access operational
safe insertion of the device to facilitate central venous access
Measured: 24 hours
Incidence of adverse events through 24 hours
no procedural adverse events or peri procedural adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start8 Feb 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050799
- Sponsor's protocol ID
- CVO-P4-23-01
- Status last verified
- Nov 2026
- First submitted
- 10 Sep 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)
- ClinicalTrials.gov ID
- NCT05050799
- Acronym / sponsor ID
- CVO-P4-23-01
- Conditions
- Venous Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
- Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
- Subjects are willing and able to give written informed consent
Key exclusion criteria (4 listed)
- Occlusion of the right femoral vein, right iliac vein or inferior vena cava
- Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
- Occlusion within the arterial system
- Occlusion within the coronary or cerebral vasculature
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central Venous AccessThe 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. | Device | – |
Primary outcome
Central Venous Access operational
Time frame: 24 hours
safe insertion of the device to facilitate central venous access
Incidence of adverse events through 24 hours
Time frame: 24 hours
no procedural adverse events or peri procedural adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Disease, run by Merit Medical Systems, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Susmeyer (978-758-6166, Hannah.Susmeyer@merit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Venous Access operational (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.