A forthcoming clinical trial aims to evaluate the PPAL, a novel medical device designed for addressing age-related challenges. Announced on November 1, 2025, this study marks a collaborative effort spearheaded by Alicia Koontz, QUA Inc., the National Institute of Nursing Research (NINR), and the National Institutes of Health (NIH). While the trial is not yet recruiting, it holds significant promise for advancements in intervention strategies for individuals experiencing age-associated difficulties. This article details the key elements of the study for clinical, quality, and regulatory professionals.
What is the PPAL clinical trial?
The PPAL is a medical device aimed at addressing functional impairments linked to aging. Though the exact specifications and mechanisms of the device remain undisclosed publicly, the involvement of reputable sponsors like the NINR and NIH highlights the study’s importance.
The clinical trial will rigorously assess the safety, performance, and intended use of the PPAL device. This step is an essential phase in establishing the product’s viability and compliance with regulatory standards. The trial is currently listed as not yet recruiting.
What regulatory steps are involved?
Medical devices like the PPAL must adhere to stringent regulation frameworks to ensure their safety and efficacy before commercialization. Given the involvement of the NIH and NINR, the clinical trial is likely to comply with Good Clinical Practice (GCP) guidelines and other regulations required for FDA or comparable certifications.
Such regulatory pathways involve evaluating the device’s risk-benefit profile, intended use, and real-world applications within the age-demographic population. Close coordination with ethical committees and regulatory authorities will also ensure patient safety during the trials.
Why is this trial significant?
The global demographic of older adults continues to increase, intensifying the focus on technological and therapeutic advancements for age-related challenges. Devices like the PPAL may potentially improve the quality of life for elderly populations, making this an area of high unmet need.
What are the next steps?
Before recruitment begins, the research team will need to finalize study protocols and secure institutional review board (IRB) approvals. Recruitment announcements and pre-enrollment activities will likely follow once these foundational steps are complete.
Participants will be screened to align with the trial’s inclusion and exclusion criteria, ensuring a robust and ethically sound study population that aligns with the device’s intended purpose.
FAQ
- 1. Who is sponsoring the clinical trial?
The trial is jointly sponsored by Alicia Koontz, QUA Inc., the National Institute of Nursing Research (NINR), and the National Institutes of Health (NIH). - 2. When will the trial start recruiting participants?
As of now, the recruitment start date has not been disclosed. The trial is listed as “not yet recruiting.” - 3. What condition does the PPAL address?
The device targets functional impairments and challenges associated with aging populations.
Conclusion
The PPAL clinical trial represents a meaningful effort to develop medical technology suited for age-related challenges. Professionals in clinical, quality, and regulatory fields will be monitoring this study closely to gain insights into the device’s performance and implications for future applications.
Further updates can be anticipated as recruitment and study execution proceed, providing additional clarity on the device’s potential impact.
Disclaimer
This article is intended for informational purposes only and should not be considered legal or regulatory advice. Medical device professionals should consult appropriate guidelines and legal frameworks for compliance specifics.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07221552?term=medical+device