The RETRAIN Trial Phase 2 is now advancing exploration into the use of two innovative medical devices aimed at preventing complications following ischaemic stroke. Professionals across regulatory, clinical, and quality sectors are encouraged to take note of this ongoing development, as the trial could inform future standard-of-care practices.
In this article:
What is the RETRAIN Trial?
The RETRAIN Trial is a clinical study focused on exploring novel device-based interventions for patients who have experienced ischaemic stroke. This second phase of the trial seeks to evaluate the safety and efficacy of these devices in preventing complications related to immobility after a stroke. Ischaemic stroke, a common type of stroke caused by a blood clot obstructing blood flow to the brain, often leads to long-term complications. The trial’s findings could play a crucial role in shaping future management protocols for stroke patients.
What Are the Devices Being Investigated?
Intermittent Pneumatic Compression (IPC)
One of the devices under investigation is an Intermittent Pneumatic Compression (IPC) device. These devices are designed to promote blood flow in the limbs, helping to reduce the risk of deep vein thrombosis (DVT) and other circulation-related complications, which are common risks for patients who are immobilized.
geko® T3
The second device, the geko® T3, is a neuromuscular electrostimulation product that provides a gentle, electrical pulse to the muscles. This stimulation mimics the body’s natural nerve signals, encouraging improved circulation and potentially reducing risks associated with limited movement, such as lower-limb blood clots.
Both devices are being assessed to determine their clinical benefits and overall safety profiles in the context of post-stroke care. Data generated from this trial can inform product registration and commercialization efforts, particularly under regulatory frameworks such as the EU Medical Device Regulation (EU MDR) or FDA requirements.
Who is Sponsoring and What is the Trial’s Status?
The RETRAIN Trial Phase 2 is sponsored by Firstkind Ltd, a medtech company known for its expertise in bioelectronic devices, in partnership with Innovate UK, a government-backed organization that supports innovation-driven industries. These sponsors are driving the exploration of advanced interventions in stroke care.
Currently, the trial is in the active recruitment phase, seeking participants who meet the criteria to contribute to the study. Given the clinical significance of the trial, both sponsors are likely working closely with regulators to navigate compliance with regional medical device requirements. More information about participation and trial updates can be accessed on ClinicalTrials.gov.
Frequently Asked Questions
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What is the goal of the RETRAIN Trial Phase 2?
The trial aims to assess the safety and effectiveness of the IPC and geko® T3 devices in preventing complications from immobilization in ischaemic stroke patients.
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Who can participate in this trial?
The trial is actively recruiting participants who meet the inclusion criteria. Details are available on the ClinicalTrials.gov website.
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Where is the study taking place?
The specific locations of trial sites are listed on the trial’s ClinicalTrials.gov page.
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How do these devices reduce risks after a stroke?
Both devices aim to improve blood circulation and minimize risks such as deep vein thrombosis, a common issue for immobilized stroke patients.
Conclusion
The RETRAIN Trial Phase 2 represents a promising advancement in post-stroke care. By evaluating the benefits of innovative devices, it could provide critical data to inform both clinical practice and regulatory pathways for new medical devices. Stakeholders are encouraged to follow developments closely.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. Always consult with qualified professionals for specific guidance related to medical devices or clinical trials.
Announcement Source
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07197996?term=medical+device