New device to improve intravenous therapy safety
A Pilot Study of a Novel Medical Device for Pharmacological Therapy: The SecHold Device
This study is testing a new device that aims to make intravenous treatments safer and more effective for patients by reducing risks like infections and catheter problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 262 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Fundacion Miguel Servet Academic / other |
| Locations | 1 site (Pamplona, Navarre) |
| Trial ID | NCT06938750 on ClinicalTrials.gov |
What this trial studies
This study focuses on validating a novel fixative device designed to enhance the safety and effectiveness of intravenous therapies. A multidisciplinary team has collaborated to create this device, which aims to reduce complications associated with vascular access and catheter use. The device allows for better control and identification of the pharmacological therapies administered to patients, potentially minimizing risks such as catheter malfunction and infection.
Who should consider this trial
Good fit: Ideal candidates for this study are patients admitted to the intensive care unit who can provide informed consent.
Not a fit: Patients with pre-existing coagulation disorders or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce complications related to intravenous therapy, improving patient outcomes in critical care settings.
How similar studies have performed: While similar approaches have been explored, this specific device represents a novel intervention in the field of vascular access management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients admitted to the intensive care unit * patients with authorization to take part in the study Exclusion Criteria: * Patients with pre-existing medical conditions: Patients with diseases affecting coagulation, such as hemophilia or thrombocytopathies, could be excluded. * Active infection patients: Any patient with vascular access site infections or systemic infections may be excluded to avoid complications. * Inability to give informed consent: Patients who are unable to understand or consent to participate in the study.
Where this trial is running
Pamplona, Navarre
- Hospital Universitario de Navarra — Pamplona, Navarre, Spain (Recruiting)
Study contacts
- Principal investigator: Marta M Ferraz-Torres, PHD — Fundación Miguel Servet
- Study coordinator: marta M FERRAZ-TORRES, PHD
- Email: marta.ferraz.torres@navarra.es
- Phone: +34628813974
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.