| NCT ID | NCT06727240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Interlinked AB |
| Condition | Intravenous Access |
| Study Type | INTERVENTIONAL |
| Enrollment | 548 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 548 participants in total. It began in 2024-03-25 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Around 1.5 billion peripheral intravenous catheters (PIVCs) are sold yearly, with up to 90% of hospitalized patients receiving one, yet failure rates can reach 69%, often due to phlebitis, infiltration, occlusion, or dislodgement. These complications can collectively be named mechanical complications. This study aims to assess a new device's effectiveness in reducing mechanical complications associated with PIVCs through a non-inferiority randomized trial at two sites. A total of 548 patients will be recruited, with primary outcomes focused on complication rates and secondary outcomes examining adverse events, healthcare feedback, and economic impacts.
Eligibility Criteria
Inclusion Criteria: * The patient has or will get a vascular access device (VAD) expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥2h and intermitted as an infusion lasting 15min to \<2h. * ≥18 years of age * Speak and understand local language * VADs already in place when the patient is admitted to the ward should not present with phlebitis or infiltration or occlusion * Participants have signed the informed consent or have a legal authorized representative (LAR) who has provided this consent Exclusion Criteria: * The VAD is expected to be used for sampling only * Pregnancy * Unable to obtain informed consent or without an available LAR to provide surrogate informed consent * Patients under palliative care * Bolus IV infusion, defined as an infusion time of \<15 min
Contact & Investigator
Ramon Mir Abellán, PhD
PRINCIPAL INVESTIGATOR
Parc Sanitari Sant Joan de Déu
Frequently Asked Questions
Who can join the NCT06727240 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intravenous Access. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06727240 currently recruiting?
Yes, NCT06727240 is actively recruiting participants. Contact the research team at christopher.blacker@uu.com for enrollment information.
Where is the NCT06727240 trial being conducted?
This trial is being conducted at Coimbra, Portugal, Barcelona, Spain.
Who is sponsoring the NCT06727240 clinical trial?
NCT06727240 is sponsored by Interlinked AB. The principal investigator is Ramon Mir Abellán, PhD at Parc Sanitari Sant Joan de Déu. The trial plans to enroll 548 participants.