MedTrace Logo

Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia

NCT05531344 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-09-07

No results posted yet for this study

Summary

This is a prospective, randomized, open-label, parallel-group, medication-control, superiority, multicenter clinical study trial.

This study is studying the effects and safety in treating patients from nine different centers with Benign prostatic hyperplasia, employing Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of hyperplasia tissue cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and urodynamic data analysis of each patient will be evaluated in each study patients.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Composite Steep-pulse Treatment Device

Applying the Composite Steep-pulse Treatment Device to treat the patients with Benign Prostatic Hyperplasia

DRUG

Tamsulosin Hydrochloride Capsules

Applying Tamsulosin Hydrochloride Capsules to treat the patients with Benign Prostatic Hyperplasia

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Dongfang Hospital Affiliated to Tongji University

    collaborator OTHER

  • Shanghai Pudong Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Ningbo No.2 Hospital

    collaborator OTHER

  • Shangdong Yiyuan Hospital

    collaborator UNKNOWN

  • Tongji Hospital

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Hunan Provincial People's Hospital

    collaborator OTHER

  • REMD Medical Technology

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-20
Primary Completion
2022-07-08
Completion
2022-07-08

Countries

  • China

Study Locations

More Related Trials

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 NCT05531344 on ClinicalTrials.gov