A new clinical trial investigating the use of radial extracorporeal shock wave therapy (ESWT) for primary lipedema is making headlines. Led by Fatih Bagcier, the trial aims to assess the potential benefits of this device-based therapy when combined with standard conservative treatments for managing lipedema. As of November 2025, the trial is not yet recruiting.
What is lipedema?
Lipedema is a chronic and often underdiagnosed medical condition characterized by the abnormal accumulation of fat tissue, usually in the lower body. It primarily affects women and has significant impacts on physical functionality, as well as emotional and mental well-being. Current treatment strategies include manual lymphatic drainage, compression garments, and, in some cases, surgical intervention.
What is the focus of this trial?
The trial, sponsored by Fatih Bagcier, aims to evaluate the clinical effectiveness and safety of radial ESWT as an adjunct to standard conservative therapy in patients diagnosed with primary lipedema. Radial ESWT devices deliver acoustic waves into affected tissue areas to stimulate processes like improved blood flow, reduction of lymphedema symptoms, and pain relief. This study explores whether integrating this device can substantially improve patient outcomes compared to standard care alone.
Radial ESWT as a promising intervention
Radial ESWT has increasingly gained attention in various medical fields for its non-invasive nature and minimal risks. The application for managing lipedema is relatively new but holds promise due to its mechanism of action. Clinical outcomes from this trial may provide necessary evidence for regulatory and clinical approvals in the future.
Who can benefit from this research?
Patients, healthcare providers, and the medical device industry may all benefit from the findings of this trial. For patients, particularly those with primary lipedema, the study offers new hope for enhanced therapeutic options. Healthcare professionals may gain a deeper understanding of advanced treatment protocols, while manufacturers of ESWT devices could harness trial data to refine regulatory submissions and adoption frameworks.
Potential implications for medical devices
Clinical trials like this can have significant regulatory implications. Positive outcomes for safety and performance could lead to enhanced market adoption of radial ESWT devices for conditions beyond musculoskeletal disorders. If proven effective, radial ESWT may feature prominently in clinical guidelines and bring additional opportunities for reimbursement policies.
FAQ
- What is radial ESWT?
Radial extracorporeal shock wave therapy uses acoustic waves to provide therapeutic effects in targeted areas. It is non-invasive, relatively painless, and commonly used in rehabilitation medicine. - Why is this trial important?
It explores new applications of radial ESWT for a condition with limited effective treatment options, potentially improving the lives of many patients. - Who is conducting the trial?
The study is sponsored by Fatih Bagcier, as listed on ClinicalTrials.gov. - Is the study currently recruiting participants?
No, recruitment has not yet begun as of November 2025.
Conclusion
Radial extracorporeal shock wave therapy is an innovative device treatment with growing applications in various medical fields. This announcement of a clinical trial exploring its role in managing primary lipedema offers a step forward for patients and stakeholders. Stakeholders in clinical, regulatory, and medical device domains should monitor results for future implications.
Disclaimer
This content is intended for informational purposes only and does not constitute legal or regulatory advice. Consult relevant authorities or professionals for specific compliance requirements.
Clinical trial details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07240415?term=medical+device