A new clinical trial is set to explore the efficacy of the ActiTENS Mini, a transcutaneous electrical nerve stimulation device, in addressing chronic pelvic pain caused by endometriosis. This trial, supported by Assistance Publique – Hôpitaux de Paris and other sponsors, could bring innovative solutions to a condition affecting millions of women worldwide. Stakeholders in clinical research and regulatory affairs should closely follow this development.
What is the trial about?
This clinical trial primarily focuses on evaluating the use of the ActiTENS Mini to alleviate chronic pain in women diagnosed with pelvic endometriosis. The study will apply weak electrical stimulation via the device to address pain-related symptoms. As of January 2026, the trial status is ‘not yet recruiting,’ indicating that participants will soon be enrolled.
The trial is sponsored by Assistance Publique – Hôpitaux de Paris with additional support from SUBLIMED, which has donated medical devices and assisted in application development, and the Ministry of Health, France. It involves two interventions, each focusing on differing electrical stimulation levels delivered by the ActiTENS Mini.
Who is participating?
This trial targets women experiencing chronic pelvic pain due to endometriosis, a condition where tissue similar to the uterus lining grows outside the uterine cavity, often resulting in severe pain and complications. Researchers aim to enroll a carefully selected participant pool to evaluate the device’s performance effectively.
Details on inclusion and exclusion criteria will likely be available as the trial progresses and recruitment begins. Clinical teams and regulatory professionals can keep track of updates via the trial’s official record.
What are the features of the ActiTENS Mini?
The ActiTENS Mini operates as a transcutaneous electrical nerve stimulation system. Specifically designed for patient comfort and adaptability, the device delivers regulated weak electrical currents to stimulate nerves and potentially block pain signals. The trial will assess both the safety and effectiveness of this technology when applied in endometriosis-related chronic pain scenarios.
SUBLIMED, a key collaborator, contributed to developing the device and its accompanying application. This partnership ensures advanced technological oversight and quality assurance during the trial.
What is the potential impact?
The results of this trial could redefine pain management for endometriosis patients. Currently, treatment options include medication, hormone therapy, or surgery, but these approaches often involve significant shortcomings, including side effects or limited efficacy.
If successful, the ActiTENS Mini could provide a noninvasive alternative that enhances quality of life for patients. Results from this trial will also offer valuable insights for future research and regulatory submissions for pain-relief medical devices.
FAQ
- 1. Is the trial accepting participants?
As of January 2026, recruitment has not yet begun. - 2. What is the purpose of the trial?
To evaluate the safety and efficacy of the ActiTENS Mini in alleviating chronic pelvic pain caused by endometriosis. - 3. Who is conducting the research?
The trial is led by Assistance Publique – Hôpitaux de Paris, with contributions from SUBLIMED and the French Ministry of Health. - 4. What is the ActiTENS Mini?
A medical device designed to deliver transcutaneous electrical nerve stimulation to manage chronic pain.
Conclusion
The ActiTENS Mini trial represents an important step in improving care for women facing chronic pelvic pain due to endometriosis. Clinical research and regulatory teams should monitor this study closely to assess its implications for pain management and device innovation. Further updates will clarify how this device may serve as a noninvasive treatment solution in the future.
Disclaimer
This content is intended for professionals in the medical and regulatory fields. It is informational only and does not constitute legal or clinical advice. Always consult the trial’s official documentation for authoritative guidance.
Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07317037?term=medical+device