Venous OcclusionSAVEUSNCT03209050

Evaluation of the Surfacer System Approach to Central Venous Access

A study testing Central Venous Access Placement in people with Venous Occlusion, run by Merit Medical Systems, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Venous Occlusion
What is being tested?: Central Venous Access Placement
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2017to 1 Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

referred for placement of central venous access catheter
have limited or diminishing upper body venous access
have pathology impeding standard access methods
willing to give written informed consent

Who cannot join

occlusion of the right femoral vein
occlusion of the iliac vein
occlusion of the inferior vena cava
contraindicated by physician
acute thrombosis within any vessel planned to be crossed by the Surfacer *tortuous anatomy which precludes a straight line from femoral vein to subclavian
diagnosed with active pericarditis

Show all 11Show fewer

diagnosed with active endocarditis
suspected pericardial effusion
known or suspected aneurysm or ectasia of ascending aorta
innominate artery or subclavian artery
pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study

Trial locations and contacts

1 site in 1 country.

United States1 site

Houston Methodist Research Institute
Houston, Texas, 77030

Other trials in United States

About this study

Read the detailed description

This prospective, single arm, multi-center study is to demonstrate the safety and efficacy of the Surfacer System. Safety will be evaluated based on the overall rate of acute complications using the study device as compared to historical rates of device/procedure related safety events using conventional central venous access methods. Efficacy will be evaluated by the rate of transient successful central venous accesses created by the study device. A total of 30 patients are planned to be enrolled, with 10 patients initially following review of safety data. Duration expected to be through 7 days. A minimum of 3 sites will participate in the study in the United States.

Conditions: Venous Occlusion
Being tested: Central Venous Access Placement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Central Venous Access PlacementDevice
Device inserted into the femoral vein to insert a central venous access catheter

Study groups in NCT03209050
Study group	Role	What they receive
Central Venous Access Placement	Other	Central venous access placement Receives: Device: Central Venous Access Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter
Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.
Measured: 7 days

Secondary outcomes (1)

Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted
Safety and Efficacy 90.0% (27/30) successful central venous catheter placements as assessed by patent open central venous access catheter. Ability to use the central venous access catheter for dialysis and infusion through 7 days
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 20171 Jun 2019

First posted6 Jul 2017
Study start18 Dec 2017
Primary completion24 May 2019
Study completion1 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous OcclusionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: patients requiring venous access
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03209050
Sponsor's protocol ID: BVT.Surfacer.17-01
Acronym: SAVEUS
Status last verified: May 2023
First submitted: 16 Jun 2017
Last updated: 30 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy

All Venous Occlusion trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Surfacer System Approach to Central Venous Access
ClinicalTrials.gov ID: NCT03209050
Acronym / sponsor ID: SAVEUS / BVT.Surfacer.17-01
Conditions: Venous Occlusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
Collaborators: Meditrial Europe Ltd.
Study start: 18 Dec 2017 (actual)
Primary completion: 24 May 2019 (actual)
Study completion: 1 Jun 2019 (actual)
First posted: 6 Jul 2017 (actual)
Results: Posted 12 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: patients requiring venous access

Arm	Type	Receives
Central Venous Access Placement	Other	Device: Central Venous Access PlacementCentral venous access placement

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

referred for placement of central venous access catheter
have limited or diminishing upper body venous access
have pathology impeding standard access methods
willing to give written informed consent

Key exclusion criteria (11 listed)

occlusion of the right femoral vein
occlusion of the iliac vein
occlusion of the inferior vena cava
contraindicated by physician
acute thrombosis within any vessel planned to be crossed by the Surfacer *tortuous anatomy which precludes a straight line from femoral vein to subclavian

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 Access PlacementDevice inserted into the femoral vein to insert a central venous access catheter	Device	Central Venous Access Placement

Primary outcome

Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter
Time frame: 7 days
Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.

1 secondary outcome

Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted
Time frame: 7 days

Results and safety

Results posted to the registry on 12 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Central Venous Access Placement	30	27

Primary outcome: Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter

Time frame: 7 days. Number. Unit: participants

Measure	Central Venous Access Placement n = 30
Value	30

Central Venous Access Placement: p = 0.5, Clopper-Pearson 95% CI

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 weeks or 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Central Venous Access Placement	4 of 30 (13.3%)	1 of 30 (3.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Venous Occlusion

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy

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. This study is not recruiting at the moment.

Monica Tocchi, MD study director

Meditrial Europe Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Central Venous Access Placement in people with Venous Occlusion, run by Merit Medical Systems, Inc. at 1 site 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03209050.

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 30 May 2023.