Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Healthy Volunteers: f
View:
• Man over 40 years old
• Indication of surgical management for BPH
• Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography
• IPSS score ≥15
• Qmax ≤12 ml/s
• Affiliated to the French national social security system
• Patient suitable for IV sedation or general anesthesia and focal microwave ablation
• Wish and able to comply with planned visits
• Able to express his consent
• Signed informed consent form
Locations
Other Locations
France
Hôpital Cochin
RECRUITING
Paris
Contact Information
Primary
Nicolas BARRY DELONGCHAMPS, MD, PHD
nicolas.barry-delongchamps@aphp.fr
+33 1 58 41 27 64
Backup
Karima MESBAHI
karima.mesbahi@aphp.fr
+33 1 58 41 12 11
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2026-08
Participants
Target number of participants: 22
Treatments
Experimental: patients with BPH
Targeted Microwave Ablation
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris