NCT06867315

The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia

Prospective, Multicenter, Randomized, Controlled, and Superiority Clinical Trial on the Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the efficacy of steep pulse ablation in treating benign prostatic hyperplasia (BPH) and to evaluate its safety profile in treating BPH. The main questions it aims to answer are: 1. whether steep pulse ablation can effectively manage BPH symptoms and to investigate any potential safety concerns associated with its use in treating BPH. 2. If steep pulse ablation can perform superior effect than Tamsulosin Hydrochloride in treating BPH. Participants will be asked to do: 1. Participants will be given Tamsulosin Hydrochloride or undergo steep pulse ablation. 2. Participants will be followed up after 1 month and 3 month after taking drug or undergo ablation for test and relative examinations.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	steep pulse therapy system	1. Use steep pulse system to ablate the transitional zone of the prostate to treat BPH 2. The steep pulse generator employs irreversible electroporation technology, which involves inserting electrodes into the tumor and delivering high-voltage electrical pulses to create nanoscale permanent pores on the lipid bilayer of tumor cell membranes. This disrupts the intracellular balance and induces cell apoptosis
DRUG	Tamsulosin Hydrochloride	1. use Tamsulosin Hydrochloride Sustained-Release Capsules to treat BPH 2. the brand name is Harnal® 3. the specification is 0.2mg per capsule

Timeline

• Start date: 2024-05-29
• Primary completion: 2026-05-29
• Completion: 2026-05-29
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: China