NCT06212453 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
| NCT ID | NCT06212453 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 22 participants in total. It began in 2024-04-24 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Unwillingness to accept the treatment * Neurological pathology responsible for micturition disorders * History of prostatic surgery * History of prostatic arterial embolization * Prostate protrusion Index of grade 2 (\>5 mm) or more as evaluated by ultrasonography. * Stenosis of the urethra * History of prostate cancer * History of radiotherapy or pelvic surgery * Life expectancy \<2 years * Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks. * Participation in another clinical study involving an investigational product within 1 month before study entry.
Contact & Investigator
Nicolas BARRY DELONGCHAMPS, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06212453 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06212453 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06212453 currently recruiting?
Yes, NCT06212453 is actively recruiting participants. Contact the research team at nicolas.barry-delongchamps@aphp.fr for enrollment information.
Where is the NCT06212453 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06212453 clinical trial?
NCT06212453 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Nicolas BARRY DELONGCHAMPS, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 22 participants.