Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia
Status:
Completed
Trial end date:
2022-07-08
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
REMD Medical Technology
Collaborators:
Dongfang Hospital Affiliated to Tongji University Hunan Provincial People's Hospital Ningbo No.2 Hospital Qilu Hospital of Shandong University RenJi Hospital Shangdong Yiyuan Hospital Shanghai Pudong Hospital Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Tongji Hospital