A planned clinical trial aims to evaluate the Dalia Monitoring device as a potential intervention for individuals experiencing chronic depression or related conditions. Sponsored by Dalia Care, the study will compare outcomes from this innovative medical device with conventional healthcare practices.
Set to begin recruitment, the trial represents a significant step in exploring novel technologies for mental health therapy. Clinical, quality, and regulatory teams may find the details especially relevant as they consider advancements in monitoring tools for depression management.
Study Overview and Objectives
This trial will investigate the use of the Dalia Monitoring device in managing conditions such as chronic depression, depressed mood, and related impacts on quality of life. Conventional healthcare practices will serve as a comparator in the study.
Key conditions addressed include:
- Chronic depression
- Depressed mood
- Impact on overall quality of life
The trial is sponsored by Dalia Care, who emphasize leveraging technology to enhance healthcare outcomes.
How Does the Dalia Monitoring Device Work?
The device’s specific details have not yet been disclosed, but monitoring tools commonly include features designed to track mood, behaviors, and possibly biometric data. By aggregating this information, such devices may support therapeutic strategies tailored to the user’s needs.
Healthcare teams might also benefit from integrated features that improve communication between patients and providers.
Regulatory Implications of the Trial
Clinical trials play a pivotal role in certifying new medical devices under regulatory guidelines such as MDR Annex XIV in Europe or corresponding frameworks globally. Dalia Care’s study aligns with these principles by focusing on the intended purpose, performance, and safety of its device.
The findings will inform stakeholders, including regulatory teams, about both risks and benefits associated with the device, guiding future decisions for market approval.
Who is affected?
Stakeholders such as healthcare providers, manufacturers, and policymakers are impacted by trials like this. Patients may also find hope in innovations targeted at improving depression management solutions.
What changed?
By preparing to launch this trial, Dalia Care signals ongoing efforts to advance treatment methods, filling gaps in conventional approaches that might not fully address chronic depression challenges.
Frequently Asked Questions
- When does recruitment begin?
Recruitment status is currently listed as “not yet recruiting.” - What conditions does the study address?
Conditions include chronic depression, depressed mood, and quality-of-life impacts. - Who sponsors the trial?
The trial is sponsored by Dalia Care.
Key Takeaways
Technology-driven interventions like the Dalia Monitoring device could redefine depression treatment strategies. Comprehensive evaluations through studies like this trial are essential for determining their feasibility, risks, and benefits.
Clinical and regulatory teams should monitor this study’s progress to assess how innovative devices can integrate with existing healthcare practices.
Disclaimer
This article provides general information about an upcoming clinical trial. It is intended for professional awareness only and does not constitute legal or medical advice.
Further Reading and Links
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07211984?term=medical+device