A new clinical trial focusing on peripheral intravenous (IV) infiltration detection is set to advance the landscape of medical device validation. The study, sponsored by ivWatch, LLC, will assess the performance and safety of its ivWatch Model 400 device. This upcoming trial is relevant for clinical, quality, and regulatory teams aiming to monitor device efficacy and compliance.
What changed?
Recently, ivWatch, LLC revealed plans for a clinical trial to assess the device’s ability to detect IV infiltration. As of November 2025, the study is listed as “Not yet recruiting” on ClinicalTrials.gov. This trial signifies growing emphasis on regulatory compliance for IV therapy devices aimed at patient safety.
How does ivWatch Model 400 work?
The ivWatch Model 400 is designed to assist healthcare providers in identifying IV therapy complications before they progress. Peripheral IV infiltration can cause discomfort, delayed treatments, and medical complications. By providing continuous monitoring, the device aims to detect fluid leakage timely and improve clinical intervention rates.
The method involves specialized sensor technology to track changes in tissue composition, signaling potential infiltration events. The company emphasizes that this device aligns with goals to minimize adverse outcomes associated with IV therapies.
What is the purpose of this trial?
This upcoming study is critical for validating the ivWatch Model 400’s performance in real-world healthcare settings. The aim is to establish the device’s ability to provide clinically reliable data. Sponsors intend to gather evidence for safety and effectiveness to meet regulatory requirements.
The trial will influence questions surrounding medical device market approvals, including the role of evidence-based design in addressing IV therapy risks.
Clinical trials like this help regulatory bodies and medical professionals evaluate whether devices meet essential health protection standards under frameworks such as MDR Annex XIV.
FAQ
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Who is conducting the trial?
The trial is sponsored by ivWatch, LLC.
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What stage is the trial in?
The study is currently listed as “Not yet recruiting,” according to ClinicalTrials.gov records.
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What area of medicine does the device address?
It is focused on detection and prevention of complications linked to IV therapy.
Conclusion
The ivWatch Model 400 trial highlights innovation in the medical device sector. By validating the device’s real-world performance for peripheral IV infiltrations, ivWatch, LLC aims to strengthen safety protocols across healthcare practices. Regulatory teams and clinical professionals should monitor developments from this initiative.
Disclaimer
This post is intended for professional readers. It is not legal advice and does not replace direct review of regulatory documentation.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07228416?term=medical+device