Teleflex vascular access device safety and performance registry
A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices
This registry will collect real-world information to see if Teleflex vascular access devices are safe and work well for patients who need central or peripheral vascular access.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Sex | All |
| Sponsor | Teleflex Industry-sponsored |
| Locations | 3 sites (Huntsville, Alabama and 2 other locations) |
| Trial ID | NCT06604039 on ClinicalTrials.gov |
What this trial studies
The registry will enroll patients who receive a range of Teleflex vascular access devices—including central venous, hemodialysis, midline, peripheral, and arterial catheters—and collect standardized clinical data during routine care. Data collection is designed to meet Level 3 MDCG 2020-6 standards and will capture device performance, complications, and clinical outcomes. Participation requires informed consent and occurs at participating hospitals where device placement and follow-up happen per usual practice. This is an observational registry and does not direct specific treatments or procedures.
Who should consider this trial
Good fit: Ideal candidates are patients who will receive a Teleflex vascular access device as part of routine care, can read English or Spanish, and can provide informed consent (or have a legally authorized representative consent where allowed).
Not a fit: Patients already enrolled in another registry or clinical investigation that could confound results, incarcerated individuals, and those unable to provide informed consent are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could give clinicians and patients clearer, real-world information about device safety and help reduce complications through better device selection and use.
How similar studies have performed: Previous device registries and postmarket surveillance programs have successfully identified safety signals and performance trends, although evidence for specific device features (such as antimicrobial or antithrombogenic properties) varies by product.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Huntsville, Alabama and 2 other locations
- Huntsville Hospital — Huntsville, Alabama, United States (Recruiting)
- Loma Linda University Health — Loma Linda, California, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Aderinola (Derin) Ogundimu, PhD, ACRP, PMP
- Email: aderinola.ogundimu@teleflex.com
- Phone: 469.569.9223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.