Actively Recruiting
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
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-01-20
22
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man over 40 years old
- Indication of surgical management for benign prostatic hyperplasia
- Prostate volume between 30 cc and 100 cc as evaluated by ultrasonography
- International Prostate Symptom Score (IPSS) of 15 or higher
- Maximum urine flow rate (Qmax) of 12 ml/s or less
- Affiliated with the French national social security system
- Suitable for intravenous sedation or general anesthesia and focal microwave ablation
- Willing and able to comply with planned visits
- Able to provide informed consent
- Signed informed consent form
You will not qualify if you...
- Unwillingness to accept the treatment
- Neurological disorders causing urination problems
- History of prostate surgery
- History of prostatic arterial embolization
- Prostate protrusion index of grade 2 (greater than 5 mm) or more by ultrasonography
- Urethral stenosis
- History of prostate cancer
- History of radiotherapy or pelvic surgery
- Life expectancy less than 2 years
- Inability to understand or voluntarily give informed consent or complete study tasks
- Participation in another clinical study involving an investigational product within 1 month before study entry
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
Research Team
N
Nicolas BARRY DELONGCHAMPS, MD, PHD
CONTACT
K
Karima MESBAHI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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