The University of Nebraska has announced an innovative clinical trial for the assessment of Peripheral Artery Disease (PAD) using a cutting-edge medical device. As of November 2025, this trial remains in the preliminary stage and is not yet recruiting.
This trial will examine the efficacy of segmental pulse arrival time assessments, a promising technique that could improve PAD diagnosis accuracy. Stakeholders in medical device regulation, clinical research, and healthcare technologies should follow these developments closely due to their potential regulatory and clinical implications.
In this article:
- What is Peripheral Artery Disease?
- What are the key details of the device?
- What is the status of the clinical trial?
- FAQ
- Conclusion
- Disclaimer
- Announcement link
What is Peripheral Artery Disease?
Peripheral Artery Disease (PAD) is a condition marked by narrowed arteries that restrict blood flow to the limbs. This can lead to serious health consequences, including pain, tissue damage, and even limb amputation in advanced cases. Detecting PAD early is essential to prevent its progression and improve patient outcomes.
What are the key details of the device?
The trial will assess a segmental pulse arrival time monitoring device. This technology measures the time it takes for a pulse to reach various locations along the arteries. Researchers hypothesize that this technique may provide better insights into vascular health compared to traditional diagnostic methods. If proven effective, this device could redefine PAD detection protocols.
What is the status of the clinical trial?
The clinical trial is sponsored by the University of Nebraska as part of its ongoing research initiatives in cardiovascular diagnostics. Currently listed as “Not yet recruiting,” the program is expected to involve a specific methodology to evaluate device performance while adhering to strict regulatory frameworks, including FDA guidelines for medical devices.
Stakeholders in regulatory affairs and clinical trial management can expect further announcements regarding participant recruitment and protocol specifics in the coming months.
FAQ
1. What makes this device different from current PAD diagnostic tools?
Current tools often use imaging or doppler ultrasound, which can be time-intensive. This device offers a simpler, quicker evaluation by measuring pulse arrival times.
2. When will recruitment begin?
The recruitment timeline has not been confirmed. Updates can be tracked via ClinicalTrials.gov.
3. Are there risks associated with the device?
Safety evaluations are part of the clinical trial process to identify and mitigate risks.
Conclusion
This research could revolutionize PAD diagnostics by simplifying detection processes and expanding patient access to critical care advancements. Clinical teams, regulators, and device developers should monitor updates for implications on medical practice and regulatory compliance.
Disclaimer
This article is intended for informational purposes only. It does not constitute legal or professional advice regarding medical devices or regulatory matters.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07226193?term=medical+device