To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China

Boston Scientific

Status: Completed

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Device: Rezūm System

Study type: Observational

Funder types: Industry

Identifiers

NCT04823221

U0719

Details and patient eligibility

About

A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study

Full description

This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population.

The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

Enrollment: 22 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subjects will provide written informed consent form and agree to data collection.
• The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.

Exclusion criteria

• This is a retrospective study without any formal exclusion criteria.

Trial design

22 participants in 1 patient group

Rezūm system

Description:

The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.

Treatment:

Device: Rezūm System