This report covers a not yet recruiting trial evaluating active bipolar radiofrequency therapy for Genitourinary Syndrome of Menopause and the regulatory considerations for this device trial.
Published February 19, 2026, the article outlines the trial sponsor and intervention options in a concise form for clinical, quality and regulatory teams.
What is the study about?
The ClinicalTrials.gov record describes a device based intervention for GSM using active bipolar radiofrequency therapy versus a sham procedure. The sponsor listed is University of Castilla La Mancha. The not yet recruiting status indicates the study is in an early phase and will be described in the public trial record as it progresses. This entry reflects a regulatory interest in energy based therapy for female health conditions.
Study design notes
The record shows two arms, active bipolar radiofrequency therapy and a sham radiofrequency procedure. The publicly available text provides limited details on sample size, endpoints or study duration. Additional details may appear in the official trial record or regulatory submissions later.
What are the regulatory implications?
From a regulatory viewpoint, devices that deliver bipolar radiofrequency energy for GSM would fall under medical device regulation. In the European Union the MDR requires safety and performance data, risk management documentation and a documented quality system if the device is intended for marketing. The trial design with a sham control aligns with standard regulatory expectations for safety comparisons and to avoid bias. The sponsor must submit information to ClinicalTrials.gov and regulatory authorities as required by law, and this entry cites the record NCT07419035.
How is the trial designed and what is its status?
The trial compares active bipolar radiofrequency therapy with a sham procedure in adults with GSM. The sponsor is University of Castilla-La Mancha and the status is not yet recruiting on ClinicalTrials.gov with the identifier NCT07419035. The high level description does not include all operational details, and readers should check the official registry for updates on enrolment, endpoints and timeline.
FAQ
- 1. What therapy is studied? The study tests active bipolar radiofrequency therapy versus a sham procedure for GSM.
- 2. What does not yet recruiting mean? It means participant enrolment has not begun.
- 3. Who sponsors the trial? University of Castilla-La Mancha is listed as sponsor.
- 4. Where can I find the trial record? The trial is registered on ClinicalTrials.gov under NCT07419035.
Conclusion
Not yet recruiting indicates early stage for the device trial. Stakeholders should monitor the public registry and sponsor updates for new information on enrolment, safety data and potential regulatory submissions. The regulatory context remains dynamic as the trial progresses.
Disclaimer: This article is intended for professionals. It is not legal advice. Always verify with primary regulatory sources and official filings.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07419035?term=medical+device