Participants in the pivotal ReCET study focused on the Endogenex System for Type 2 Diabetes may soon benefit from extended device access. This clinical trial update, announced on September 29, 2025, highlights important changes for stakeholders across clinical, quality, and regulatory teams, especially in relation to patient support and ongoing system evaluation.
What changed?
Endogenex, Inc., the sponsor of the ReCET Pivotal Study, has confirmed that participants will retain access to the Endogenex System beyond the initial study timeline. This decision aligns with regulatory strategies to ensure patient continuity while expanding data on device performance and safety. The trial, currently listed as “Not yet recruiting,” focuses on exploring efficacy for Type 2 Diabetes Mellitus, a chronic condition requiring advanced treatment interventions.
Who is affected?
This update directly impacts clinical trial participants, sponsoring organizations, and regulatory teams monitoring progress. Healthcare providers and diabetes specialists should take note, as extended patient access may influence treatment pathways. Additionally, manufacturers should prepare for evolving performance review processes governed under applicable medical device regulations.
Regulatory context
The Endogenex System is categorized as a medical device aimed at improving outcomes for Type 2 Diabetes Mellitus patients. Under MDR Annex XIV guidelines, sponsors and investigators must balance safety and performance while advancing clinical discovery. Ensuring continued participant access serves this dual purpose, permitting broader analysis of device effectiveness in real-world settings. ClinicalTrials.gov lists the study with its current status as “Not yet recruiting,” which may signal forthcoming enrollment waves.
This regulatory move provides an opportunity for stakeholders across healthcare systems to monitor compliance frameworks and stay updated on performance metrics associated with devices treating chronic conditions like Type 2 Diabetes.
Frequently Asked Questions
1. Who sponsors the ReCET Pivotal Study?
The study is sponsored by Endogenex, Inc., a company specializing in diabetes-related medical devices.
2. What conditions are addressed in this trial?
The trial focuses specifically on Type 2 Diabetes Mellitus.
3. Has enrollment started?
No, the ClinicalTrials.gov listing indicates the status as “Not yet recruiting.”
4. What is the primary intervention?
The study evaluates the use of the Endogenex System as the primary device intervention.
Conclusion
Continued access to the Endogenex System for ReCET Pivotal Study participants marks a key development in diabetes device trials. Stakeholders must stay informed as additional regulatory and performance details emerge. Both industry professionals and healthcare teams should remain prepared for evolving compliance and treatment considerations.
Disclaimer
This content is for informational purposes and should not be construed as legal advice. Ensure assessment aligns with specific regulatory requirements and professional guidance.
Full announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07197788?term=medical+device