Vascular Access DeviceVADERNCT06604039
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
An observational study of Vascular Access Device, run by Teleflex at 3 sites in United States.
Trial summary
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Access Device
- What is being tested?
- Central venous catheter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 2,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Dec 2024to 7 Dec 2034
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Subjects who are scheduled to receive a vascular access procedure using at least one Teleflex vascular access device will be considered for enrollment.
Who may be able to join
- Subjects will undergo a procedure that will include use of a Teleflex device covered by this Research.
- Subject is willing and capable of providing informed consent and/or give approval to collect, store and process limited health information by the Sponsor; or such consent is provided by a legally designated representative if required by local law or regulation.
- Subjects is able to read and understand English or Spanish languages
Who cannot join
- Subject is currently participating in another clinical Registry or investigation that may confound the results of this Registry.
- Subject was previously failed screening or was enrolled in this clinical Registry.
- Subject is imprisoned
- Subject is cognitively impaired and unable to provide informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Haval Chweich, MD, haval.chweich1@tuftsmedicine.org
- Recruiting
Huntsville Hospital
Huntsville, Alabama, 35801
Sara Couey, DNP, CRNP, sara.couey@hhsys.org
- Recruiting
Loma Linda University Health
Loma Linda, California, 92354
Melissa McCabe, MD, MSCR, mmccabe@llu.edu
Sarah Capalla, MSN, RN, scapalla@llu.edu
About this study
Official title: A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
Read the detailed description
The primary objective is to provide high-quality data, as defined by Medical Device Coordination group (MDCG) 2020-6, on the performance and clinical benefits of Teleflex's vascular access devices when used in a real-world setting. The hypothesis is that, when used in accordance with the instructions for use (IFU), the vascular access devices will perform safely and successfully.
The Teleflex vascular access devices (index devices and accessories) in scope for this Registry vary in type from central venous access devices (CVAD) to midline catheters to peripheral catheters to hemodialysis catheters to arterial catheters navigation/tip confirmation devices. Many, but not all, of the devices also have antimicrobial and antithrombogenic properties. Also in scope are the accessories routinely used for placement and maintenance of the index devices.
- Conditions
- Vascular Access Device
- Being tested
- Central venous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous catheterDevice
Also called Peripherally inserted central catheter, Dialysis catheter, Midline intravenous catheter, Peripheral intravenous catheter
Placement of a medical device to gain entry into the bloodstream, typically through a vein or artery, for the purpose of administering fluids, medications, blood products, or for hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Subject | Needing a vascular access device for therapy or diagnosis Receives: Device: Central venous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter devices: successful use of the device without removal due to device-related adverse events
The proportion of device uses successfully completed without device removal due to device-related adverse events
Measured: Within 7 days after subject device removal
Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location
Successful verification of catheter tip location
Measured: Immediately after subject device removal
Secondary outcomes (2)
Device-related adverse events
Incidence of device-related adverse events during placement or use
Measured: Within 7 days after subject device removal
Device-related adverse events within 7 days of device removal
Incidence of device-related adverse events following removal
Measured: Within 7 days after subject device removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Dec 2024
- Primary completion7 Dec 2034 (estimated)
- Study completion7 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access DeviceStudies 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teleflex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Brinker, Study director, Teleflex Incorporated Clinical and Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604039
- Sponsor's protocol ID
- 2024-02
- Acronym
- VADER
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this time
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices
- ClinicalTrials.gov ID
- NCT06604039
- Acronym / sponsor ID
- VADER / 2024-02
- Conditions
- Vascular Access Device
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- TeleflexIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2024 (actual)
- Primary completion
- 7 Dec 2034 (estimated)
- Study completion
- 7 Dec 2034 (estimated)
- First posted
- 19 Sep 2024 (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.
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
Detailed description
The primary objective is to provide high-quality data, as defined by Medical Device Coordination group (MDCG) 2020-6, on the performance and clinical benefits of Teleflex's vascular access devices when used in a real-world setting. The hypothesis is that, when used in accordance with the instructions for use (IFU), the vascular access devices will perform safely and successfully.
The Teleflex vascular access devices (index devices and accessories) in scope for this Registry vary in type from central venous access devices (CVAD) to midline catheters to peripheral catheters to hemodialysis catheters to arterial catheters navigation/tip confirmation devices. Many, but not all, of the devices also have antimicrobial and antithrombogenic properties. Also in scope are the accessories routinely used for placement and maintenance of the index devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject | – | Device: Central venous catheterNeeding a vascular access device for therapy or diagnosis |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who are scheduled to receive a vascular access procedure using at least one Teleflex vascular access device will be considered for enrollment.
Key inclusion criteria (3 listed)
- Subjects will undergo a procedure that will include use of a Teleflex device covered by this Research.
- Subject is willing and capable of providing informed consent and/or give approval to collect, store and process limited health information by the Sponsor; or such consent is provided by a legally designated representative if required by local law or regulation.
- Subjects is able to read and understand English or Spanish languages
Key exclusion criteria (4 listed)
- Subject is currently participating in another clinical Registry or investigation that may confound the results of this Registry.
- Subject was previously failed screening or was enrolled in this clinical Registry.
- Subject is imprisoned
- Subject is cognitively impaired and unable to provide informed consent
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 catheterAlso: Peripherally inserted central catheter, Dialysis catheter, Midline intravenous catheter, Peripheral intravenous catheterPlacement of a medical device to gain entry into the bloodstream, typically through a vein or artery, for the purpose of administering fluids, medications, blood products, or for hemodialysis | Device | Subject |
Primary outcome
Catheter devices: successful use of the device without removal due to device-related adverse events
Time frame: Within 7 days after subject device removal
The proportion of device uses successfully completed without device removal due to device-related adverse events
Arrow VPS Rhythm DXL catheter tip positioning system: Successful verification of catheter tip location
Time frame: Immediately after subject device removal
Successful verification of catheter tip location
2 secondary outcomes
Device-related adverse events
Time frame: Within 7 days after subject device removal
Device-related adverse events within 7 days of device removal
Time frame: Within 7 days after subject device removal
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 7 Oct 2026.
- Individual participant dataSharing planned: Undecided. Undecided at this time
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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.
Laura Brinker study director
Teleflex Incorporated Clinical and Medical Affairs
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Device, run by Teleflex at 3 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Samson Odeyemi (9402904684, samson.odeyemi@teleflex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter devices: successful use of the device without removal due to device-related adverse events (time frame: Within 7 days after subject device removal). 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 7 Oct 2026.