Who is sponsoring NCT05531344?

NCT05531344 is sponsored by REMD Medical Technology.

What condition does NCT05531344 study?

NCT05531344 studies Benign Prostatic Hyperplasia.

What drugs are being tested in NCT05531344?

Interventions: Composite Steep-pulse Treatment Device, Tamsulosin Hydrochloride Capsules.

What is the status of NCT05531344?

NCT05531344 is currently COMPLETED.

Last reviewed 2022-09-07 · How we verify

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

NCT05531344 PHASE2, PHASE3 COMPLETED

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.

Details

Lead sponsor	REMD Medical Technology
Phase	PHASE2, PHASE3
Status	COMPLETED
Enrolment	160
Start date	Thu Aug 20 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Jul 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Benign Prostatic Hyperplasia

Interventions

Composite Steep-pulse Treatment Device
Tamsulosin Hydrochloride Capsules

Countries

China