CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Rezūm Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04823221
NCT04823221N/ACompleted

A Real World Study to Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China (Rezūm RWS Study)

Boston Scientific Corporation·observational·Posted Mar 30, 2021·Updated Mar 2, 2022

In Brief

An observational study evaluating Rezūm System for Benign Prostatic Hyperplasia (BPH). Completed, enrolled 22 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 30, 2021
Enrollment StartJul 10, 2021
Primary CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 21 daysPosted 5.3 years ago

Interventions

Rezūm Systemdevice

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.