Feima Medical Launches Multicenter Clinical Trial of Prostate Steam Ablation System in Collaboration with Nanjing Gulou Hospital

On December 25, 2025, the clinical trial titled “Evaluation of the Safety and Efficacy of Thermal Vapor Therapy Devices and Disposable Prostate Thermal Vapor Therapy Instruments for the Treatment of Benign Prostatic Hyperplasia,” sponsored by Suzhou Feima Medical and led by the Department of Urology at Nanjing Drum Tower Hospital, officially enrolled its first patient at Nanjing Drum Tower Hospital. This milestone marks the formal entry into the clinical trial phase of the thermal vapor therapy devices and instruments independently developed by Suzhou Feima Medical.

The investigational device for this clinical trial is the "Thermal Vapor Therapy Device and Disposable Prostate Thermal Vapor Therapy Device." A multicenter, randomized controlled, non-inferiority clinical trial design was adopted. The clinical safety and effectiveness of the thermal vapor therapy device and the disposable prostate thermal vapor therapy device were evaluated through comparative analysis of primary endpoints, secondary endpoints, and safety endpoints.

Thermal Vapor Therapy Device and Disposable Thermal Vapor Therapy Instrument for Prostate, Primarily Used for the Treatment of Patients Aged 50 Years and Older with a Prostate Volume of 30-80 cm³³Patients with benign prostatic hyperplasia.

Benign prostatic hyperplasia (BPH) is a common condition among middle-aged and elderly men, with a prevalence exceeding 50% in Chinese men over the age of 60, significantly impairing their quality of life. Traditional treatment modalities, such as pharmacotherapy, are associated with notable side effects, while surgical interventions involve substantial trauma. Furthermore, existing minimally invasive techniques still face challenges, including operational complexity and prolonged recovery periods. Pegasus Medical’s independently developed water vapor thermal therapy system, along with its配套 disposable instruments, ablates hyperplastic tissue through precisely controlled high-temperature water vapor energy. This approach offers advantages such as minimal trauma, short operative time, rapid recovery, and preservation of sexual function. The technology has completed multicenter clinical studies overseas, with its efficacy and safety recognized internationally. It has been incorporated into authoritative clinical guidelines in major countries and regions, including the United States, Europe, Canada, the United Kingdom, Australia, Japan, and South Korea, as a minimally invasive treatment option for BPH.

This clinical trial is led by Professor Guo Hongqian from the Department of Urology at Nanjing Drum Tower Hospital as the Principal Investigator (PI), with a team comprising authoritative experts in the field of urology in China. As a National Regional Medical Center, Nanjing Drum Tower Hospital’s Department of Urology handles over 100,000 outpatient visits annually and has accumulated extensive experience in the diagnosis and treatment of benign prostatic hyperplasia (BPH). Its rigorous clinical research system will provide a solid guarantee for the reliability of the trial data.

Established in 1953, the Department of Urology is a Key Medical Discipline of Jiangsu Province, a Key Clinical Specialty of Jiangsu Province, and a Key Medical Discipline of Nanjing City. It is designated as the Da Vinci Surgical Robot Clinical Teaching and Demonstration Center for Urological Surgery in China, authorized by the National Health Commission; the Clinical Application Demonstration Center for Cryoablation Technology (Argon-Helium Knife) in China; the Training Base for Endoscopic Diagnosis and Treatment Technology under the Ministry of Health; the National Clinical Pharmacology Base for Urological Tumors; and the Robotic Surgical Treatment Center of Jiangsu Province. The department serves as a master’s and doctoral degree granting unit for Nanjing University Medical School, Nanjing Medical University, Southeast University Medical School, and Nanjing University of Chinese Medicine.

Director of the Urology Institute, Nanjing University; Chief Physician; Professor at Nanjing University; Doctoral Supervisor at Nanjing University and Nanjing Medical University; Recipient of the State Council’s Special Government Allowance. Currently serves as Chairman of the Committee on Urinary System Diseases of the Jiangsu Provincial Quality Control Association; Vice Chairman of the Urology Branch of the Jiangsu Provincial Association of Integrative Medicine; Deputy Leader of the Endourology Group under the Urology Branch of the Jiangsu Medical Association; Member of the Asian Society for Cryotherapy; Member of the Urology Branch of the Jiangsu Medical Association; Member of the Organ Transplantation Branch of the Jiangsu Medical Association; Chairman of the Young Urologists Committee of the Nanjing Medical Association; Chairman of the Urology Branch of the Nanjing Medical Association. Also serves as Associate Editor-in-Chief of the Chinese Journal of Surgical Oncology, and Editorial Board Member of the National Journal of Andrology, Journal of Modern Urology, Chinese Journal of Minimally Invasive Surgery, and Journal of Clinical Urology. Honored with titles such as “National Health System Young Post Expert,” “Nanjing Top Ten Outstanding Youths,” and “Nanjing Young and Middle-aged Experts with Outstanding Contributions.” Selected as a Key Talent in Jiangsu Province’s “Six Major Talent Peaks” Program and the “333 Project.” Has presided over more than 10 national and provincial/ministerial-level research projects. Over the past five years, his team has published more than 100 SCI-indexed papers and over 200 articles in national core journals, won seven Jiangsu Provincial Medical New Technology Introduction Awards and three municipal-level Science and Technology Progress Awards, and published five monographs. Primary clinical and research interests include the diagnosis and treatment of urogenital tumors, kidney transplantation, minimally invasive urology, and urinary stones.