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

NCT06867315 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of University of Science and Technology of China

    collaborator OTHER

  • First People's Hospital of Hangzhou

    collaborator OTHER

  • Fujian Provincial Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2026-05-29
Completion
2026-05-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867315 on ClinicalTrials.gov